Document ID: FDA-2015-M-0201-0002
Agency: fda
Document Type: Notice
Title: Medical Devices; Availability of Safety and Effectiveness Summaries for
Premarket Approval Applications
Posted Date: 2015-09-29T04:00Z

[Federal Register Volume 80, Number 188 (Tuesday, September 29, 2015)]
[Notices]
[Pages 58488-58489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24625]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-M-2375, FDA-2015-M-0909, FDA-2015-M-0199, FDA-
2015-M-0200, FDA-2015-M-0201, FDA-2015-M-0228, FDA-2015-M-0266, FDA-
2015-M-0267, FDA-2015-M-0431, FDA-2015-M-0502, FDA-2015-M-0690, FDA-
2015-M-0738, FDA-2015-M-0910]

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: Submit written requests for copies of summaries of safety 
and effectiveness data to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852. Please cite the appropriate docket number as listed in table 
1 when submitting a written request. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the summaries of safety and 
effectiveness.

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 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, 2015, through March 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 January 1, 2015,
                                             Through March 31, 2015
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         PMA No., Docket No.                    Applicant                    Trade name            Approval date
----------------------------------------------------------------------------------------------------------------
P980040/S049, FDA-2014-M-2375.......  Abbott Medical Optics, Inc..  TECNIS[supreg] multifocal 1-      12/17/2014
                                                                     piece intraocular lens.
P140010, FDA-2015-M-0199............  Medtronic, Inc..............  IN.PACTTM AdmiralTM               12/30/2014
                                                                     Paclitaxel-coated
                                                                     Percutaneous Transluminal
                                                                     Angioplasty Balloon
                                                                     Catheter.
P130019, FDA-2015-M-0201............  EnteroMedics, Inc...........  Maestro[supreg] Rechargeable       1/14/2015
                                                                     System.
P130025, FDA-2015-M-0200............  Koning Corp.................  Koning Breast CT (Model CBCT       1/14/2015
                                                                     1000).
P060001/S020, FDA-2015-M-0228.......  ev3, Inc....................  Prot[eacute]g[eacute]TM GPS        1/21/2015
                                                                     Self-Expanding Peripheral
                                                                     Stent System.
H140001, FDA-2015-M-0267............  ABIOMED, Inc................  Impella RP System...........       1/23/2015

[[Page 58489]]

 
P140017, FDA-2015-M-0266............  Medtronic, Inc..............  MelodyTM Transcatheter             1/27/2015
                                                                     Pulmonary Valve (TPV) and
                                                                     EnsembleTM Transcatheter
                                                                     Valve Delivery System.
P130023, FDA-2015-M-0431............  Cohera Medical, Inc.........  TissuGlu[supreg] Surgical           2/3/2015
                                                                     Adhesive.
P010047/S036, FDA-2015-M-0502.......  NeoMend, Inc................  ProGelTM Pleural Air Leak          2/13/2015
                                                                     Sealant.
P140018, FDA-2015-M-0690............  Covidien, LLC...............  VenaSealTM Closure System...       2/20/2015
H130001, FDA-2015-M-0909............  Biologics Consulting Group,   Lixelle Beta 2-microglobulin        3/5/2015
                                       Inc..                         Apheresis Column.
P110024, FDA-2015-M-0738............  Advanced Circulatory          ResQCPRTM System............        3/6/2015
                                       Systems, Inc..
P130013, FDA-2015-M-0910............  Boston Scientific Corp......  WATCHMANTM Left Atrial             3/13/2015
                                                                     Appendage (LAA) Closure
                                                                     Technology.
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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: September 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24625 Filed 9-28-15; 8:45 am]
 BILLING CODE 4164-01-P