Document ID: FDA-2015-M-2217-0002
Agency: fda
Document Type: Notice
Title: Medical Devices: Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Posted Date: 2015-11-18T05:00Z

[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]

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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.

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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: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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
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                                                                                                       Approval
           PMA No., docket No.                      Applicant                    Trade name              date
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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..
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II. Electronic Access

    Persons with access to the Internet may obtain the documents at 
http://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]
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