Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 72067-72068 [2015-29450]

Download as PDF Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Notices addition to data collection for the certification of QHPs, the reinsurance and risk adjustment programs outlined by the Affordable Care Act, detailed in 45 CFR part 153, as established by CMS–9975–F, Patient Protection and Affordable Care Act; Standards for Reinsurance, Risk Corridors, and Risk Adjustment (77 FR 17220), published in March 23, 2012, have general information reporting requirements that apply to issuers, group health plans, third party administrators, and plan offerings outside of the Exchanges. Subsequent regulations for these programs including the final HHS Notice of Benefit and Payment Parameters for 2014 and the Program Integrity: Exchange, Premium Stabilization Programs, and Market Standards; Amendments to the HHS Notice of Benefit and Payment Parameters for 2014 provide further reporting requirements. Form Number: CMS–10433 (OMB Control Number 0938–1187); Frequency: Annually; Affected Public: States and Private Sector; Number of Respondents: 26,951; Number of Responses: 26,951; Total Annual Hours: 235,153. (For questions regarding this collection contact Leigha Basini at 301–492–4380.) Dated: November 12, 2015. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2015–M–1707, FDA– 2015–M–2218, FDA–2015–M–2217, FDA– 2015–M–2497, FDA–2015–M–2219, FDA– 2015–M–2499, FDA–2015–M–2634, FDA– 2015–M–2584, FDA–2015–M–2618, FDA– 2015–M–2739, FDA–2015–M–2740, and FDA–2015–M–2964] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Food and Drug Administration, asabaliauskas on DSK5VPTVN1PROD with NOTICES 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 SUMMARY: VerDate Sep<11>2014 18:50 Nov 17, 2015 Jkt 238001 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 [FR Doc. 2015–29343 Filed 11–17–15; 8:45 am] AGENCY: Agency’s Division of Dockets Management. 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–1707, FDA–2015–M–2218, FDA–2015–M–2217, FDA–2015–M– 2497, FDA–2015–M–2219, FDA–2015– M–2499, FDA–2015–M–2634, FDA– 2015–M–2584, FDA–2015–M–2618, FDA–2015–M–2739, FDA–2015–M– 2740, and FDA–2015–M–2964 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 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 72067 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: Melissa Torres, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993–0002, 301–796–5576. 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 E:\FR\FM\18NON1.SGM 18NON1 72068 Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Notices 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 July 1, 2015, through September 30, 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 JULY 1, 2015, THROUGH SEPTEMBER 30, 2015 PMA No., docket No. Applicant Trade name P930016/S044, FDA–2015–M–1707 ........ AMO Manufacturing USA, LLC ................ P120024, FDA–2015–M–2218 ................. P140021, FDA–2015–M–2217 ................. Aesculap Implant Systems, LLC .............. Roche Diagnostics Operations, Inc .......... P140009, FDA–2015–M–2497 ................. P140025, FDA–2015–M–2219 ................. P140031, FDA–2015–M–2499 ................. St. Jude Medical Neuromodulation .......... Ventana Medical Systems, Inc ................. Edwards Lifesciences, LLC ...................... P040024/S073, FDA–2015–M–2634 ........ H080004, FDA–2015–M–2584 ................. Galderma Laboratories L.P. ..................... Integrum AB .............................................. P140028, FDA–2015–M–2618 ................. Boston Scientific Corporation ................... P140013, FDA–2015–M–2739 ................. P140012, FDA–2015–M–2740 ................. Minerva Surgical, Inc ................................ ReShape Medical, Inc .............................. P140008, FDA–2015–M–2964 ................. Apollo Endosurgery, Inc ........................... STAR S4 IR Exciter Laser System and iDesign WaveScan Studio System. activL® Artificial Disc ................................ Elecsys® Anti-HCV II Immunoassay and Elecsys® PreciControl Anti-HCV. Brio Neurostimulation System .................. VENTANA ALK (D5F3) CDx Assay ......... SAPIEN 3TM Transcatheter Heart Valve and Accessories. Restylane Lyft with Lidocaine ................... Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA). InnovaTM Vascular Self-Expanding Stent System. MinervaTM Endometrial Ablation System. ReShape Integrated Dual Balloon System. ORBERATM Intragastric Balloon System. 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: November 13, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–29450 Filed 11–17–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration asabaliauskas on DSK5VPTVN1PROD with NOTICES [Docket No. FDA–2008–D–0530] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Tropical Disease Priority Review Vouchers AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Sep<11>2014 20:14 Nov 17, 2015 The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). DATES: Fax written comments on the collection of information by December 18, 2015. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-New and title ‘‘Guidance for Industry on Tropical Disease Priority Review Vouchers.’’ Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUMMARY: Jkt 238001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 Approval date 5/6/2015 6/11/2015 6/11/2015 6/12/2015 6/12/2015 6/17/2015 7/1/2015 7/16/2015 7/21/2015 7/27/2015 7/28/2015 8/5/2015 In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Guidance for Industry on Tropical Disease Priority Review Vouchers— OMB Control Number 0910–NEW Section 1102 of the Food and Drug Administration Amendments Act (FDAAA) adds new section 524 to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360n). Section 524 is designed to encourage development of new drug or biological products for prevention and treatment of certain tropical diseases affecting millions of people throughout the world and makes provisions for awarding priority review vouchers for future applications to sponsors of tropical disease products. By enacting section 524, Congress intended to stimulate new drug development for drugs to treat certain tropical diseases for which there are no or few available treatments by offering additional incentives for obtaining FDA approval for pharmaceutical treatments for these diseases. Under section 524, a sponsor of a human drug application for a E:\FR\FM\18NON1.SGM 18NON1

Agencies

[Federal Register Volume 80, Number 222 (Wednesday, November 18, 2015)]
[Notices]
[Pages 72067-72068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29450]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-M-1707, FDA-2015-M-2218, FDA-2015-M-2217, FDA-
2015-M-2497, FDA-2015-M-2219, FDA-2015-M-2499, FDA-2015-M-2634, FDA-
2015-M-2584, FDA-2015-M-2618, FDA-2015-M-2739, FDA-2015-M-2740, and
FDA-2015-M-2964]

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-1707, FDA-2015-M-2218, FDA-2015-M-2217, FDA-2015-M-2497,
FDA-2015-M-2219, FDA-2015-M-2499, FDA-2015-M-2634, FDA-2015-M-2584,
FDA-2015-M-2618, FDA-2015-M-2739, FDA-2015-M-2740, and FDA-2015-M-2964
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: Melissa Torres, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-5576.

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

[[Page 72068]]

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 July 1, 2015, through September 30,
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 July 1, 2015, Through
September 30, 2015
----------------------------------------------------------------------------------------------------------------
Approval
PMA No., docket No. Applicant Trade name date
----------------------------------------------------------------------------------------------------------------
P930016/S044, FDA-2015-M-1707............ AMO Manufacturing USA, LLC. STAR S4 IR Exciter Laser 5/6/2015
System and iDesign
WaveScan Studio System.
P120024, FDA-2015-M-2218................. Aesculap Implant Systems, activL[supreg] Artificial 6/11/2015
LLC. Disc.
P140021, FDA-2015-M-2217................. Roche Diagnostics Elecsys[supreg] Anti-HCV II 6/11/2015
Operations, Inc. Immunoassay and
Elecsys[supreg]
PreciControl Anti-HCV.
P140009, FDA-2015-M-2497................. St. Jude Medical Brio Neurostimulation 6/12/2015
Neuromodulation. System.
P140025, FDA-2015-M-2219................. Ventana Medical Systems, VENTANA ALK (D5F3) CDx 6/12/2015
Inc. Assay.
P140031, FDA-2015-M-2499................. Edwards Lifesciences, LLC.. SAPIEN 3\TM\ Transcatheter 6/17/2015
Heart Valve and
Accessories.
P040024/S073, FDA-2015-M-2634............ Galderma Laboratories L.P.. Restylane Lyft with 7/1/2015
Lidocaine.
H080004, FDA-2015-M-2584................. Integrum AB................ Osseoanchored Prostheses 7/16/2015
for the Rehabilitation of
Amputees (OPRA).
P140028, FDA-2015-M-2618................. Boston Scientific Innova\TM\ Vascular Self- 7/21/2015
Corporation. Expanding Stent System.
P140013, FDA-2015-M-2739................. Minerva Surgical, Inc...... Minerva\TM\ Endometrial 7/27/2015
Ablation System..
P140012, FDA-2015-M-2740................. ReShape Medical, Inc....... ReShape Integrated Dual 7/28/2015
Balloon System.
P140008, FDA-2015-M-2964................. Apollo Endosurgery, Inc.... ORBERA\TM\ Intragastric 8/5/2015
Balloon System..
----------------------------------------------------------------------------------------------------------------

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: November 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29450 Filed 11-17-15; 8:45 am]
BILLING CODE 4164-01-P

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