Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 6865-6866 [2016-02522]

Download as PDF Federal Register / Vol. 81, No. 26 / Tuesday, February 9, 2016 / Notices meeting registration is available at: https://eclkc.ohs.acf.hhs.gov/hslc/hs/ calendar/tc2016. DEPARTMENT OF HEALTH AND HUMAN SERVICES HHS announces OHS Tribal Consultations for leaders of Tribal Governments operating Head Start and Early Head Start programs. The agenda for the scheduled OHS Tribal Consultations in Albuquerque, New Mexico, Arlington, Virginia, and Spokane, Washington, will be organized around the statutory purposes of Head Start Tribal Consultations related to meeting the needs of American Indian and Alaska Native children and families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations. In addition, OHS will share actions taken and in progress to address the issues and concerns raised in the 2015 OHS Tribal Consultations. The Consultation Sessions will be conducted with elected or appointed leaders of Tribal Governments and their designated representatives [42 U.S.C. 9835, section 640(l)(4)(A)]. Designees must have a letter from the Tribal Government authorizing them to represent the tribe. Tribal Governments must submit the designee letter at least 3 days in advance of the Consultation Session to Angie Godfrey at Angie.Godfrey@acf.hhs.gov. Other representatives of tribal organizations and Native nonprofit organizations are welcome to attend as observers. A detailed report of each Consultation Session will be prepared and made available within 45 days of the Consultation Sessions to all Tribal Governments receiving funds for Head Start and Early Head Start programs. Tribes wishing to submit written testimony for the report should send testimony to Angie Godfrey at Angie.Godfrey@acf.hhs.gov either prior to each Consultation Session or within 30 days after each meeting. OHS will summarize oral testimony and comments from the Consultation Session in each report without attribution, along with topics of concern and recommendations. mstockstill on DSK4VPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: Dated: February 2, 2016. Blanca E. Enriquez, Director, Office of Head Start. [FR Doc. 2016–02580 Filed 2–8–16; 8:45 am] BILLING CODE 4184–01–P VerDate Sep<11>2014 17:54 Feb 08, 2016 Jkt 238001 Food and Drug Administration [Docket Nos. FDA–2015–M–3256, FDA– 2015–M–3257, FDA–2015–M–3258, FDA– 2015–M–3376, FDA–2015–M–3377, FDA– 2015–M–3516, FDA–2015–M–3516, FDA– 2015–M–3519, FDA–2015–M–3520, FDA– 2015–M–3521, FDA–2015–M–4013, FDA– 2015–M–4014, FDA–2015–M–4015, FDA– 2015–M–4016, FDA–2015–M–4017, FDA– 2015–M–4018, FDA–2015–M–4069, FDA– 2015–M–4343, FDA–2015–M–4344, FDA– 2015–M–4434, FDA–2015–M–4728, FDA– 2015–M–4947, and FDA–2015–M–4951] 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 (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. SUMMARY: 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’’). PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 6865 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–3256, FDA–2015–M–3257, FDA–2015–M–3258, FDA–2015–M– 3376, FDA–2015–M–3377, FDA–2015– M–3516, FDA–2015–M–3516, FDA– 2015–M–3519, FDA–2015–M–3520, FDA–2015–M–3521, FDA–2015–M– 4013, FDA–2015–M–4014, FDA–2015– M–4015, FDA–2015–M–4016, FDA– 2015–M–4017, FDA–2015–M–4018, FDA–2015–M–4069, FDA–2015–M– 4343, FDA–2015–M–4344, FDA–2015– M–4434, FDA–2015–M–4728, FDA– 2015–M–4947, and FDA–2015–M–4951 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 E:\FR\FM\09FEN1.SGM 09FEN1 6866 Federal Register / Vol. 81, No. 26 / Tuesday, February 9, 2016 / Notices 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 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. 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 October 1, 2015, through December 31, 2015. 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 OCTOBER 1, 2015, THROUGH DECEMBER 31, 2015 PMA No., Docket No. Applicant Trade name ........... ........... ........... ........... Fidia Farmaceutici, S.p.A. ............ Biomimetic Therapeutics, LLC ..... OrthogenRx, Inc. .......................... Tandem Diabetes Care, Inc. ........ P140016, FDA–2015–M–3377 ........... P070015/S128, FDA–2015–M–3516 Cook Medical Inc. ......................... Abbott Vascular ............................ P110019/S075, FDA–2015–M–3516 Abbott Vascular ............................ P050047/S044, FDA–2015–M–3519 P120010/S046, FDA–2015–M–4013 Allergan ........................................ Medtronic, Inc. .............................. P150003, FDA–2015–M–4014 ........... Boston Scientific Corporation ....... P150013, FDA–2015–M–3520 ........... P100034/S013, FDA–2015–M–4015 P150025, FDA–2015–M–4016 ........... P130009/S034, FDA–2015–M–4017 Dako North America, Inc. ............. Novocure, Ltd. .............................. Dako North America, Inc. ............. Edwards Lifesciences, LLC .......... P150014, FDA–2015–M–4069 ........... P150015, FDA–2015–M–4018 ........... P140019, FDA–2015–M–4343 ........... P120019/S007, FDA–2015–M–4344 P130028, FDA–2015–M–4434 ........... P150019, FDA–2015–M–4728 ........... P010030/S056, FDA–2015–M–3521 Roche Molecular Systems, Inc. ... Roche Molecular Systems, Inc. ... Cerapedics, Inc. ........................... Roche Molecular Systems, Inc. ... Algostim, LLC ............................... Medtronic MiniMed ....................... ZOLL Manufacturing Corporation P140030, FDA–2015–M–4947 ........... Biotronik, Inc. ................................ P980044/S027, FDA–2015–M–4951 Seikagaku Corporation ................. HYMOVIS® .............................................................. Augment® Bone Graft .............................................. GenVisc 850® .......................................................... t:slim G4 Insulin Pump With Dexcom G4 Platinum CGM. Zenith Alpha Thoracic Endovascular Graft .............. XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System. XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System, XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System, and XIENCE Alpine Everolimus Eluting Coronary Stent System. ´ Juvederm Ultra XC injectable gel ............................ MiniMed 530G System with Threshold Suspend featuring SmartGuardTM technology. SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System. PD–L1 IHC 22C3 pharmDx ..................................... OptuneTM (Formerly the NovoTTF–100A System) PD–L1 IHC 28–8 pharmDx ...................................... Edwards SAPIEN XTTM Transcatheter Heart Valve, model 9300TFX, and Accessories. cobas® HBV ............................................................. cobas® HCV ............................................................ i-FACTORTM Peptide Enhanced Bone Graft ........... cobas® EGFR Mutation Test v2 .............................. Algovita Spinal Cord Stimulation System ................ Paradigm Real-Time Revel System ........................ LifeVest Wearable Cardioverter Defibrillator Models 3000, 3100, and 4000. Astron Peripheral Self-Expanding Nitinol Stent System. VISCO–3TM .............................................................. mstockstill on DSK4VPTVN1PROD with NOTICES P150010, P100006, P140005, P140015, FDA–2015–M–3256 FDA–2015–M–3257 FDA–2015–M–3258 FDA–2015–M–3376 II. Electronic Access Persons with access to the Internet may obtain the documents at https:// www.fda.gov/MedicalDevices/Products andMedicalProcedures/Device VerDate Sep<11>2014 17:54 Feb 08, 2016 Jkt 238001 ApprovalsandClearances/PMA Approvals/default.htm. PO 00000 Approval date 8/28/2015 9/1/2015 9/2/2015 9/8/2015 9/15/2015 9/23/2015 9/23/2015 9/30/2015 10/2/2015 10/2/2015 10/2/2015 10/5/2015 10/9/2015 10/9/2015 10/14/2015 10/14/2015 11/3/2015 11/13/2015 11/20/2015 12/7/2015 12/17/2015 12/17/2015 12/21/2015 Dated: February 2, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–02522 Filed 2–8–16; 8:45 am] BILLING CODE 4164–01–P Frm 00039 Fmt 4703 Sfmt 9990 E:\FR\FM\09FEN1.SGM 09FEN1

Agencies

[Federal Register Volume 81, Number 26 (Tuesday, February 9, 2016)]
[Notices]
[Pages 6865-6866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02522]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-M-3256, FDA-2015-M-3257, FDA-2015-M-3258, FDA-
2015-M-3376, FDA-2015-M-3377, FDA-2015-M-3516, FDA-2015-M-3516, FDA-
2015-M-3519, FDA-2015-M-3520, FDA-2015-M-3521, FDA-2015-M-4013, FDA-
2015-M-4014, FDA-2015-M-4015, FDA-2015-M-4016, FDA-2015-M-4017, FDA-
2015-M-4018, FDA-2015-M-4069, FDA-2015-M-4343, FDA-2015-M-4344, FDA-
2015-M-4434, FDA-2015-M-4728, FDA-2015-M-4947, and FDA-2015-M-4951]

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-3256, FDA-2015-M-3257, FDA-2015-M-3258, FDA-2015-M-3376,
FDA-2015-M-3377, FDA-2015-M-3516, FDA-2015-M-3516, FDA-2015-M-3519,
FDA-2015-M-3520, FDA-2015-M-3521, FDA-2015-M-4013, FDA-2015-M-4014,
FDA-2015-M-4015, FDA-2015-M-4016, FDA-2015-M-4017, FDA-2015-M-4018,
FDA-2015-M-4069, FDA-2015-M-4343, FDA-2015-M-4344, FDA-2015-M-4434,
FDA-2015-M-4728, FDA-2015-M-4947, and FDA-2015-M-4951 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

[[Page 6866]]

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 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 October 1, 2015, through December 31,
2015. 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 October 1, 2015,
Through December 31, 2015
----------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P150010, FDA-2015-M-3256............... Fidia Farmaceutici, HYMOVIS[supreg]............. 8/28/2015
S.p.A..
P100006, FDA-2015-M-3257............... Biomimetic Therapeutics, Augment[supreg] Bone Graft.. 9/1/2015
LLC.
P140005, FDA-2015-M-3258............... OrthogenRx, Inc.......... GenVisc 850[supreg]......... 9/2/2015
P140015, FDA-2015-M-3376............... Tandem Diabetes Care, t:slim G4 Insulin Pump With 9/8/2015
Inc.. Dexcom G4 Platinum CGM.
P140016, FDA-2015-M-3377............... Cook Medical Inc......... Zenith Alpha Thoracic 9/15/2015
Endovascular Graft.
P070015/S128, FDA-2015-M-3516.......... Abbott Vascular.......... XIENCE V and XIENCE nano 9/23/2015
Everolimus Eluting Coronary
Stent System.
P110019/S075, FDA-2015-M-3516.......... Abbott Vascular.......... XIENCE PRIME and XIENCE 9/23/2015
PRIME LL Everolimus Eluting
Coronary Stent System,
XIENCE Xpedition, XIENCE
Xpedition SV and XIENCE
Xpedition LL Everolimus
Eluting Coronary Stent
System, and XIENCE Alpine
Everolimus Eluting Coronary
Stent System.
P050047/S044, FDA-2015-M-3519.......... Allergan................. Juv[eacute]derm Ultra XC 9/30/2015
injectable gel.
P120010/S046, FDA-2015-M-4013.......... Medtronic, Inc........... MiniMed 530G System with 10/2/2015
Threshold Suspend featuring
SmartGuardTM technology.
P150003, FDA-2015-M-4014............... Boston Scientific SYNERGYTM Everolimus-Eluting 10/2/2015
Corporation. Platinum Chromium Coronary
Stent System.
P150013, FDA-2015-M-3520............... Dako North America, Inc.. PD-L1 IHC 22C3 pharmDx...... 10/2/2015
P100034/S013, FDA-2015-M-4015.......... Novocure, Ltd............ OptuneTM (Formerly the 10/5/2015
NovoTTF-100A System).
P150025, FDA-2015-M-4016............... Dako North America, Inc.. PD-L1 IHC 28-8 pharmDx...... 10/9/2015
P130009/S034, FDA-2015-M-4017.......... Edwards Lifesciences, LLC Edwards SAPIEN XTTM 10/9/2015
Transcatheter Heart Valve,
model 9300TFX, and
Accessories.
P150014, FDA-2015-M-4069............... Roche Molecular Systems, cobas[supreg] HBV........... 10/14/2015
Inc..
P150015, FDA-2015-M-4018............... Roche Molecular Systems, cobas[supreg] HCV........... 10/14/2015
Inc..
P140019, FDA-2015-M-4343............... Cerapedics, Inc.......... i-FACTORTM Peptide Enhanced 11/3/2015
Bone Graft.
P120019/S007, FDA-2015-M-4344.......... Roche Molecular Systems, cobas[supreg] EGFR Mutation 11/13/2015
Inc.. Test v2.
P130028, FDA-2015-M-4434............... Algostim, LLC............ Algovita Spinal Cord 11/20/2015
Stimulation System.
P150019, FDA-2015-M-4728............... Medtronic MiniMed........ Paradigm Real-Time Revel 12/7/2015
System.
P010030/S056, FDA-2015-M-3521.......... ZOLL Manufacturing LifeVest Wearable 12/17/2015
Corporation. Cardioverter Defibrillator
Models 3000, 3100, and 4000.
P140030, FDA-2015-M-4947............... Biotronik, Inc........... Astron Peripheral Self- 12/17/2015
Expanding Nitinol Stent
System.
P980044/S027, FDA-2015-M-4951.......... Seikagaku Corporation.... VISCO-3TM................... 12/21/2015
----------------------------------------------------------------------------------------------------------------

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: February 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02522 Filed 2-8-16; 8:45 am]
BILLING CODE 4164-01-P

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