Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 31944-31945 [2016-11856]

Download as PDF 31944 Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices Advisory Committee and Oversight Management Staff, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993–0002, 301–796–8220. SUPPLEMENTARY INFORMATION: Under section 10(d) of the Federal Advisory Committee Act (5 U.S.C. app.) and 21 CFR 14.60(d), FDA has filed with the Library of Congress the annual reports for the following FDA advisory committees that held closed meetings during the period October 1, 2014 through September 30, 2015: Center for Biologics Evaluation and Research Blood Products Advisory Committee National Center for Toxicological Research Science Board to the National Center for Toxicological Research Center for Drug Evaluation and Research Bone, Reproductive Health Drugs Advisory Committee Joint Meetings of the Anesthetic and Analgesic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Annual Reports are available for public inspections between 9 a.m. and 4 p.m., Monday through Friday. 1. The Library of Congress, Madison Bldg., Newspaper and Current Periodical Reading Room, 101 Independence Ave. SE., Rm. 133, Washington, DC; and 2. The Dockets Management Branch (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: May 16, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016–11853 Filed 5–19–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES mstockstill on DSK3G9T082PROD with NOTICES Food and Drug Administration [Docket Nos. FDA–2015–M–4948, FDA– 2015–M–4949, FDA–2015–M–4950, FDA– 2016–M–0120, FDA–2016–M–0121, FDA– 2016–M–0122, FDA–2016–M–0123, FDA– 2016–M–0803, FDA–2016–M–0804, FDA– 2016–M–0805, FDA–2016–M–0806, FDA– 2016–M–0807, FDA–2016–M–0926, FDA– 2016–M–0928] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 17:40 May 19, 2016 Jkt 238001 ACTION: Notice. The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (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: SUMMARY: 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– 2015–M–4948, FDA–2015–M–4949, FDA–2015–M–4950, FDA–2016–M– 0120, FDA–2016–M–0121, FDA–2016– M–0122, FDA–2016–M–0123, FDA– PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 2016–M–0803, FDA–2016–M–0804, FDA–2016–M–0805, FDA–2016–M– 0806, FDA–2016–M–0807, FDA–2016– M–0926, FDA–2016–M–0928 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 E:\FR\FM\20MYN1.SGM 20MYN1 Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993–0002, 301–796–6524. SUPPLEMENTARY INFORMATION: I. Background In accordance with sections 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. 31945 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 January 1, 2016, through March 31, 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 JANUARY 1, 2016, THROUGH MARCH 31, 2016 PMA No., Docket No. Applicant Trade name H130006, FDA–2015–M–4950 H140005, FDA–2015–M–4948 Torax Medical, Inc .................. ARUP Laboratories ................. 12/18/2015 12/18/2015 H140006, FDA–2015–M–4949 ARUP Laboratories ................. P130007/S004, FDA–2016–M– 0120. P900033/S042, FDA–2016–M– 0121. P080028, FDA–2016–M–0122 P150011, FDA–2016–M–0123 P150027, FDA–2016–M–0803 P150004, FDA–2016–M–0804 P150022, FDA–2016–M–0805 P120018, FDA–2016–M–0806 P150005, FDA–2016–M–0807 P130009/S037, FDA–2016–M– 0926. P020004/S123, FDA–2016–M– 0928. Animas Corp ........................... FENIX Continence Restoration System ................................... PDGFRB FISH for Gleevec Eligibility in Myelodysplastic Syndrome/Myeloproliferative Disease (MDS/MPD). KIT D816V Mutation Detection by PCR for Gleevec Eligibility in Aggressive Systemic Mastocytosis (ASM). Animas Vibe System ................................................................ 1/7/2016 Storz Medical Ag .................... LivaNova Canada Corp .......... Dako North America, Inc ........ Spinal Modulation, Inc ............ Rex Medical, L.P .................... Sharps Terminator, LLC ......... Boston Scientific Corp ............ Edwards Lifesciences, LLC .... Integra Omnigraft Dermal Regeneration Matrix and Integra Dermal Regeneration Template. Storz Medical Duolith SD1 Shock Wave Therapy ................... Perceval Sutureless Heart Valve ............................................. PD–L1 IHC 28–8 pharmDx ...................................................... Axium Neurostimulator System ................................................ Closer Vascular Sealing System ............................................. Sharps Terminator ................................................................... Blazer Open-Irrigated Ablation Catheter System .................... SAPIEN XT Transcatheter Heart Valve and Accessories ....... 1/8/2016 1/8/2016 1/23/2016 2/11/2016 2/12/2016 2/17/2016 2/24/2016 2/29/2016 W.L. Gore & Associates, Inc .. GORE EXCLUDER Iliac Branch Endoprosthesis .................... 2/29/2016 Integra LifeSciences Corp ...... II. Electronic Access Persons with access to the Internet may obtain the documents at https:// www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/ DeviceApprovalsandClearances/ PMAApprovals/default.htm. ACTION: Notice of availability. ADDRESSES: Food and Drug Administration [Docket No. FDA–2007–D–0133] DATES: SUMMARY: Dated: May 16, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–11856 Filed 5–19–16; 8:45 am] BILLING CODE 4164–01–P mstockstill on DSK3G9T082PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability Food and Drug Administration, HHS. VerDate Sep<11>2014 17:40 May 19, 2016 Jkt 238001 12/18/2015 12/24/2015 You may submit comments as follows: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment.’’ This guidance is intended to assist sponsors in designing a clinical development program for new drug products for the treatment of chronic obstructive pulmonary disease (COPD). This guidance revises the draft guidance of the same name, issued November 9, 2007, by adding information regarding the St. George’s Respiratory Questionnaire (SGRQ). AGENCY: Approval date Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 19, 2016. PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 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. E:\FR\FM\20MYN1.SGM 20MYN1

Agencies

[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)]
[Notices]
[Pages 31944-31945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11856]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-M-4948, FDA-2015-M-4949, FDA-2015-M-4950, FDA-
2016-M-0120, FDA-2016-M-0121, FDA-2016-M-0122, FDA-2016-M-0123, FDA-
2016-M-0803, FDA-2016-M-0804, FDA-2016-M-0805, FDA-2016-M-0806, FDA-
2016-M-0807, FDA-2016-M-0926, FDA-2016-M-0928]

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 (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-2015-M-4948, FDA-2015-M-4949, FDA-2015-M-4950, FDA-2016-M-0120,
FDA-2016-M-0121, FDA-2016-M-0122, FDA-2016-M-0123, FDA-2016-M-0803,
FDA-2016-M-0804, FDA-2016-M-0805, FDA-2016-M-0806, FDA-2016-M-0807,
FDA-2016-M-0926, FDA-2016-M-0928 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

[[Page 31945]]

Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6524.

SUPPLEMENTARY INFORMATION:

I. Background

In accordance with sections 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 January 1, 2016, through March 31,
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 January 1, 2016,
Through March 31, 2016
----------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
H130006, FDA-2015-M-4950.............. Torax Medical, Inc....... FENIX Continence Restoration 12/18/2015
System.
H140005, FDA-2015-M-4948.............. ARUP Laboratories........ PDGFRB FISH for Gleevec 12/18/2015
Eligibility in
Myelodysplastic Syndrome/
Myeloproliferative Disease
(MDS/MPD).
H140006, FDA-2015-M-4949.............. ARUP Laboratories........ KIT D816V Mutation Detection 12/18/2015
by PCR for Gleevec
Eligibility in Aggressive
Systemic Mastocytosis (ASM).
P130007/S004, FDA-2016-M-0120......... Animas Corp.............. Animas Vibe System........... 12/24/2015
P900033/S042, FDA-2016-M-0121......... Integra LifeSciences Corp Integra Omnigraft Dermal 1/7/2016
Regeneration Matrix and
Integra Dermal Regeneration
Template.
P080028, FDA-2016-M-0122.............. Storz Medical Ag......... Storz Medical Duolith SD1 1/8/2016
Shock Wave Therapy.
P150011, FDA-2016-M-0123.............. LivaNova Canada Corp..... Perceval Sutureless Heart 1/8/2016
Valve.
P150027, FDA-2016-M-0803.............. Dako North America, Inc.. PD-L1 IHC 28-8 pharmDx....... 1/23/2016
P150004, FDA-2016-M-0804.............. Spinal Modulation, Inc... Axium Neurostimulator System. 2/11/2016
P150022, FDA-2016-M-0805.............. Rex Medical, L.P......... Closer Vascular Sealing 2/12/2016
System.
P120018, FDA-2016-M-0806.............. Sharps Terminator, LLC... Sharps Terminator............ 2/17/2016
P150005, FDA-2016-M-0807.............. Boston Scientific Corp... Blazer Open-Irrigated 2/24/2016
Ablation Catheter System.
P130009/S037, FDA-2016-M-0926......... Edwards Lifesciences, LLC SAPIEN XT Transcatheter Heart 2/29/2016
Valve and Accessories.
P020004/S123, FDA-2016-M-0928......... W.L. Gore & Associates, GORE EXCLUDER Iliac Branch 2/29/2016
Inc. Endoprosthesis.
----------------------------------------------------------------------------------------------------------------

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: May 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-11856 Filed 5-19-16; 8:45 am]
BILLING CODE 4164-01-P

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