Document ID: FDA-2015-M-3377-0002
Agency: fda
Document Type: Notice
Title: Medical Devices; Availability of Safety and Effectiveness Summaries for
Premarket Approval Applications
Posted Date: 2016-02-09T05:00Z

[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]

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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.

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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-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 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

[[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: 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: 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
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          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 
http://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]
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