Document ID: FDA-2014-M-2247-0001
Agency: fda
Document Type: Notice
Title: Medical Devices; Availability of Safety and Effectiveness Summaries for
Premarket Approval Applications
Posted Date: 2015-10-06T04:00Z

[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Notices]
[Pages 60393-60394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25352]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-M-1064, FDA-2015-M-1065, FDA-2015-M-1177, FDA-
2015-M-1178, FDA-2015-M-1325, FDA-2015-M-1326, FDA-2015-M-1460, FDA-
2015-M-1461, FDA-2015-M-1557, FDA-2015-M-1708, FDA-2015-M-1709, FDA-
2015-M-1956, FDA-2015-M-1957, FDA-2015-M-1958, FDA-2015-M-1959, FDA-
2015-M-2077, FDA-2015-M-2078, FDA-2014-M-2247]

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

[[Page 60394]]

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 April 1, 2015, through June 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 April 1, 2015 Through
                                                  June 30, 2015
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          PMA No., Docket No.                   Applicant                    Trade name            Approval date
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P140003, FDA-2015-M-1177..............  ABIOMED, Inc.............  Impella[supreg] 2.5 System...       3/23/2015
P130014, FDA-2015-M-1065..............  HyperBranch Medical        Adherus[supreg] AutoSpray           3/30/2015
                                         Technology, Inc.           Dural Sealant.
P130021/S010, FDA-2015-M-1064.........  Medtronic CoreValve, LLC.  Medtronic CoreValve[supreg]         3/30/2015
                                                                    System.
P110015, FDA-2015-M-1178..............  Advanced Breath            Gastric Emptying Breath Test         4/6/2015
                                         Diagnostics, LLC.          (GEBT).
P040020/S050, FDA-2015-M-1325.........  Alcon Research, Ltd......  AcrySof IQ ReSTOR +2.5 D            4/13/2015
                                                                    Multifocal Intraocular Lens.
P120023, FDA-2015-M-1326..............  AcuFocusTM, Inc..........  KAMRATM inlay................       4/17/2015
H130007, FDA-2014-M-2247..............  CVRx[supreg], Inc........  Barostim neoTM Legacy System.      12/12/2014
P140011, FDA-2015-M-1460..............  Siemens Medical Solutions  MAMMOMAT Inspiration with           4/21/2015
                                         USA, Inc.                  Tomosynthesis Option.
P120017, FDA-2015-M-1461..............  Medtronic, Inc...........  Model 5071 Lead..............       4/27/2015
P130012, FDA-2015-M-1557..............  Greatbatch Medical.......  Myopore Sutureless Myocardial       4/30/2015
                                                                    Pacing Lead.
P140023, FDA-2015-M-1708..............  Roche Molecular Systems,   cobas[supreg] KRAS Mutation          5/7/2015
                                         Inc.                       Test.
P130022, FDA-2015-M-1709..............  Nevro Corp...............  Nevro Senza Spinal Cord              5/8/2015
                                                                    Stimulation (SCS) System.
P140026, FDA-2015-M-1956..............  Silk Road Medical, Inc...  ENROUTETM Transcarotid Stent        5/18/2015
                                                                    System.
P140004, FDA-2015-M-1957..............  Vertiflex[supreg], Inc...  Superion[supreg] InterSpinous       5/20/2015
                                                                    Spacer.
P140002, FDA-2015-M-1958..............  Terumo Medical Corp......  Misago[supreg] Peripheral           5/22/2015
                                                                    Self-expanding Stent System.
P120005/S031, FDA-2015-M-1959.........  Dexcom, Inc..............  Dexcom G4[supreg]PLATINUM           5/22/2015
                                                                    (Pediatric) Continuous
                                                                    Glucose Monitoring System.
P110010/S096, FDA-2015-M-2077.........  Boston Scientific Corp...  PROMUS[supreg] ElementTM Plus        6/1/2015
                                                                    and Promus PREMIERTM
                                                                    Everolimus-Eluting Platinum
                                                                    Chromium Coronary Stent
                                                                    System (MonorailTM and Over-
                                                                    the-Wire).
P050052/S049, FDA-2015-M-2078.........  Merz North America.......  Radiesse[supreg] Injectable          6/4/2015
                                                                    Implant.
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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 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25352 Filed 10-5-15; 8:45 am]
 BILLING CODE 4164-01-P