Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 51453-51455 [2016-18508]

Download as PDF 51453 Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of responses per respondent Number of respondents Activity Second postcard .................................................................. Survey .................................................................................. 60 35 Total annual responses 1 1 60 35 Average burden per response Total hours .03 (2 min.) .33 (20 min.) 2 12 Main Study Survey invitation letter ......................................................... Reminder postcard ............................................................... Non-response letter ............................................................. Non-response questionnaire letter ....................................... Second postcard .................................................................. Survey .................................................................................. 5,042 5,042 4,173 4,073 3,063 1,765 1 1 1 1 1 1 5,042 5,042 4,173 4,073 3,063 1,765 Total .............................................................................. ........................ ........................ ........................ 1 There min.) min.) min.) min.) min.) min.) 403 151 334 326 92 582 ........................ 1927 are no capital costs or operating and maintenance costs associated with this collection of information. II. References The following references are on display in the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https:// www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. sradovich on DSK3GMQ082PROD with NOTICES .08 (5 .03 (2 .08 (5 .08 (5 .03 (2 .33 (20 1. Aikin, K.J., J.L. Swasy, and A.C. Braman, ‘‘Patient and Physician Attitudes and Behaviors Associated With DTC Promotion of Prescription Drugs—Summary of FDA Survey Research Results,’’ 2004. (https:// www.fda.gov/downloads/Drugs/Science Research/ResearchAreas/DrugMarketing AdvertisingandCommunicationsResearch/ ucm152860.pdf). 2. PhRMA Guiding Principles: Direct-toConsumer Advertisements About Prescription Medicines 2008. (https:// phrma.org/sites/default/files/pdf/ phrmaguidingprinciplesdec08final.pdf). 3. Dillman, D.A., J.D. Smyth, and L.M. Christian, Internet, Phone, Mail, and MixedMode Surveys: The Tailored Design Method, 4th ed. Hoboken, NJ: John Wiley & Sons, Inc., 2014. 4. American Association for Public Opinion Research, ‘‘Address-based Sampling,’’ 2016. (https://www.aapor.org/ AAPOR_Main/media/MainSiteFiles/AAPOR_ Report_1_7_16_CLEAN-COPY-FINAL.pdf). 5. Millar, M.M. and D.A. Dillman, ‘‘Improving Response to Web and MixedMode Surveys,’’ Public Opinion Quarterly 1– 21. 2011. 6. Shaw, M.J., T.J. Beebe, H.L. Jensen, and S.A. Adlis, ‘‘The Use of Monetary Incentives in a Community Survey: Impact on Response Rates, Data Quality, and Cost,’’ Health Services Research 35:1339–1346. 2011. 7. Montaquila, J.M., J.M. Brick, D. Williams, K. Kim, et al., ‘‘A Study of TwoPhase Mail Survey Data Collection Methods,’’ VerDate Sep<11>2014 18:12 Aug 03, 2016 Jkt 238001 Journal of Survey Statistics and Methodology 1(1), 66–87. 2013. Dated: July 29, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–18425 Filed 8–3–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2012–N–1210; FDA– 2004–N–0258] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Labeling: Nutrition Facts and Supplement Facts Label and Reference Amounts Customarily Consumed per Eating Occasion AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Food Labeling: Nutrition Facts and Supplement Facts Label and Reference Amounts Customarily Consumed Per Eating Occasion’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On May 27, 2016, the Agency submitted a proposed collection of information entitled ‘‘Food Labeling: Nutrition Facts SUMMARY: PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 and Supplement Facts Label and Reference Amounts Customarily Consumed Per Eating Occasion’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0813. The approval expires on July 31, 2019. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: August 1, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–18509 Filed 8–3–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2016–M–1122, FDA– 2016–M–1123, FDA–2016–M–1124, FDA– 2016–M–1125, FDA–2016–M–1165, FDA– 2016–M–1166, FDA–2016–M–1167, FDA– 2016–M–1168, FDA–2016–M–1222, FDA– 2016–M–1223, FDA–2016–M–1400, FDA– 2016–M–1401, FDA–2016–M–1455, FDA– 2016–M–1459, FDA–2016–M–1754, and FDA–2016–M–1755] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is publishing a list of premarket approval applications SUMMARY: E:\FR\FM\04AUN1.SGM 04AUN1 51454 Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency’s Division of Dockets Management. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions sradovich on DSK3GMQ082PROD with NOTICES Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket Nos. FDA– 2016–M–1122, FDA–2016–M–1123, FDA–2016–M–1124, FDA–2016–M– 1125, FDA–2016–M–1165, FDA–2016– M–1166, FDA–2016–M–1167, FDA– 2016–M–1168, FDA–2016–M–1222, FDA–2016–M–1223, FDA–2016–M– 1400, FDA–2016–M–1401, FDA–2016– M–1455, FDA–2016–M–1459, FDA– 2016–M–1754, and FDA–2016–M–1755 for ‘‘Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993–0002, 301–796–6524. SUPPLEMENTARY INFORMATION: I. Background In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the FD&C Act. The 30-day period for requesting reconsideration of an FDA action under § 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision. The regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA approvals and denials that were announced during that quarter. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the Internet from April 1, 2016, through June 30, 2016. There were no denial actions during this period. The list provides the manufacturer’s name, the product’s generic name or the trade name, and the approval date. TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM APRIL 1, 2016, THROUGH JUNE 30, 2016 PMA No., Docket No. Applicant Trade name P100044/S018, FDA–2016–M–1123 ....... P150028, FDA–2016–M–1122 ................ P150026, FDA–2016–M–1124 ................ Intersect ENT .......................................... NuMed, Inc .............................................. Cardiofocus, Inc ...................................... PROPEL® Mini Sinus Implant ................. Cheatham Platinum Stent System .......... HeartLight Endoscopic Ablation System VerDate Sep<11>2014 18:12 Aug 03, 2016 Jkt 238001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\04AUN1.SGM 04AUN1 Approval date 3/23/2016 3/25/2016 4/1/2016 Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices 51455 TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM APRIL 1, 2016, THROUGH JUNE 30, 2016—Continued PMA No., Docket No. Applicant Trade name P150033, FDA–2016–M–1125 ................ Medtronic, Inc .......................................... P140003/S005, FDA–2016–M–1165 ....... P150041, FDA–2016–M–1167 ................ P150016, FDA–2016–M–1166 ................ P130001, FDA–2016–M–1168 ................ P150012, FDA–2016–M–1222 ................ Abiomed, Inc ........................................... Abbott Molecular, Inc .............................. Neomend, Inc .......................................... Epigenomics AG ...................................... Boston Scientific Corporation .................. P130029/S002, FDA–2016–M–1223 ....... P160002, FDA–2016–M–1400 ................ P070014/S037, FDA–2016–M–1455 ....... P110033/S018, FDA–2016–M–1401 ....... P150047, FDA–2016–M–1459 ................ P150024, FDA–2016–M–1754 ................ P150029, FDA–2016–M–1755 ................ Bard Peripheral Vascular, Inc ................. Ventana Medical Systems, Inc ................ Bard Peripheral Vascular, Inc ................. Allergan ................................................... Roche Molecular Systems, Inc ............... Aspire Bariatrics, Inc ............................... Medtronic Minimed, Inc ........................... Medtronic MicraTM Transcatheter Pacemaker System. Impella Left Ventricular Support System Vysis CLL FISH Probe Kit ....................... TRIDYNETM Vascular Sealant ................ Epi proColon ............................................ ImageReady MR Conditional Pacing System and Ingevity Pace/Sense Lead. Fluency® Plus Endovascular Stent Graft VENTANA PD–L1(SP142) Assay ........... Bard® LifeStent Vascular Stent System ´ JUVEDERM VOLBELLA® XC ................. cobas® EGFR Mutation Test v2 ............. AspireAssist® ........................................... iPro2 Continuous Glucose Monitoring System With Enlite Sensor. II. Electronic Access Submit either electronic or written comments on the collection of information by October 3, 2016. ADDRESSES: You may submit comments as follows: DATES: Persons with access to the Internet may obtain the documents at https:// www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/ DeviceApprovalsandClearances/ PMAApprovals/default.htm. Electronic Submissions Dated: August 1, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–18508 Filed 8–3–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–2066] Agency Information Collection Activities; Proposed Collection; Comment Request; Certification of Identity for Freedom of Information Act and Privacy Act Requests AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on ‘‘Certification of Identity for Freedom of Information Act and Privacy Act Requests.’’ sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:12 Aug 03, 2016 Jkt 238001 Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 Approval date 4/6/2016 4/7/2016 4/11/2016 4/11/2016 4/12/2016 4/25/2016 4/26/2016 5/18/2016 5/31/2016 5/31/2016 6/1/2016 6/14/2016 6/17/2016 • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2016–N–2066 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Certification of Identity for Freedom of Information Act and Privacy Act Requests.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover E:\FR\FM\04AUN1.SGM 04AUN1

Agencies

[Federal Register Volume 81, Number 150 (Thursday, August 4, 2016)]
[Notices]
[Pages 51453-51455]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18508]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-M-1122, FDA-2016-M-1123, FDA-2016-M-1124, FDA-
2016-M-1125, FDA-2016-M-1165, FDA-2016-M-1166, FDA-2016-M-1167, FDA-
2016-M-1168, FDA-2016-M-1222, FDA-2016-M-1223, FDA-2016-M-1400, FDA-
2016-M-1401, FDA-2016-M-1455, FDA-2016-M-1459, FDA-2016-M-1754, and
FDA-2016-M-1755]

Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications

[[Page 51454]]

(PMAs) that have been approved. This list is intended to inform the
public of the availability of safety and effectiveness summaries of
approved PMAs through the Internet and the Agency's Division of Dockets
Management.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket Nos.
FDA-2016-M-1122, FDA-2016-M-1123, FDA-2016-M-1124, FDA-2016-M-1125,
FDA-2016-M-1165, FDA-2016-M-1166, FDA-2016-M-1167, FDA-2016-M-1168,
FDA-2016-M-1222, FDA-2016-M-1223, FDA-2016-M-1400, FDA-2016-M-1401,
FDA-2016-M-1455, FDA-2016-M-1459, FDA-2016-M-1754, and FDA-2016-M-1755
for ``Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6524.

SUPPLEMENTARY INFORMATION:

I. Background

In accordance with section 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the FD&C Act. The
30-day period for requesting reconsideration of an FDA action under
Sec. 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a
PMA begins on the day the notice is placed on the Internet. Section
10.33(b) provides that FDA may, for good cause, extend this 30-day
period. Reconsideration of a denial or withdrawal of approval of a PMA
may be sought only by the applicant; in these cases, the 30-day period
will begin when the applicant is notified by FDA in writing of its
decision.
The regulations provide that FDA publish a quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the Internet from April 1, 2016, through June 30, 2016.
There were no denial actions during this period. The list provides the
manufacturer's name, the product's generic name or the trade name, and
the approval date.

Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From April 1, 2016, Through
June 30, 2016
----------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P100044/S018, FDA-2016-M-1123........... Intersect ENT............. PROPEL[supreg] Mini Sinus 3/23/2016
Implant.
P150028, FDA-2016-M-1122................ NuMed, Inc................ Cheatham Platinum Stent 3/25/2016
System.
P150026, FDA-2016-M-1124................ Cardiofocus, Inc.......... HeartLight Endoscopic 4/1/2016
Ablation System.

[[Page 51455]]

P150033, FDA-2016-M-1125................ Medtronic, Inc............ Medtronic MicraTM 4/6/2016
Transcatheter Pacemaker
System.
P140003/S005, FDA-2016-M-1165........... Abiomed, Inc.............. Impella Left Ventricular 4/7/2016
Support System.
P150041, FDA-2016-M-1167................ Abbott Molecular, Inc..... Vysis CLL FISH Probe Kit.. 4/11/2016
P150016, FDA-2016-M-1166................ Neomend, Inc.............. TRIDYNETM Vascular Sealant 4/11/2016
P130001, FDA-2016-M-1168................ Epigenomics AG............ Epi proColon.............. 4/12/2016
P150012, FDA-2016-M-1222................ Boston Scientific ImageReady MR Conditional 4/25/2016
Corporation. Pacing System and
Ingevity Pace/Sense Lead.
P130029/S002, FDA-2016-M-1223........... Bard Peripheral Vascular, Fluency[supreg] Plus 4/26/2016
Inc. Endovascular Stent Graft.
P160002, FDA-2016-M-1400................ Ventana Medical Systems, VENTANA PD-L1(SP142) Assay 5/18/2016
Inc.
P070014/S037, FDA-2016-M-1455........... Bard Peripheral Vascular, Bard[supreg] LifeStent 5/31/2016
Inc. Vascular Stent System.
P110033/S018, FDA-2016-M-1401........... Allergan.................. JUV[Eacute]DERM 5/31/2016
VOLBELLA[supreg] XC.
P150047, FDA-2016-M-1459................ Roche Molecular Systems, cobas[supreg] EGFR 6/1/2016
Inc. Mutation Test v2.
P150024, FDA-2016-M-1754................ Aspire Bariatrics, Inc.... AspireAssist[supreg]...... 6/14/2016
P150029, FDA-2016-M-1755................ Medtronic Minimed, Inc.... iPro2 Continuous Glucose 6/17/2016
Monitoring System With
Enlite Sensor.
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

Persons with access to the Internet may obtain the documents at
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.

Dated: August 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18508 Filed 8-3-16; 8:45 am]
BILLING CODE 4164-01-P

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