Document ID: FDA-2012-M-1012-0002
Agency: fda
Document Type: Notice
Title: Safety and Effectiveness Summaries for Premarket Approval Applications; Availability: Medical Devices
Posted Date: 2013-03-21T04:00Z

[Federal Register Volume 78, Number 55 (Thursday, March 21, 2013)]
[Notices]
[Pages 17415-17416]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06429]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2012-M-1012, FDA-2012-M-1039, FDA-2012-M-1048, FDA-
2012-M-1049, FDA-2012-M-1066, FDA-2012-M-1084, FDA-2012-M-1085, FDA-
2012-M-1088, FDA-2012-M-1109, FDA-2012-M-1110, FDA-2012-M-1111, FDA-
2012-M-1146, FDA-2012-M-1176, FDA-2012-M-1183, and FDA-2012-M-1184]

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 of this document when submitting a written request. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the 
summaries of safety and effectiveness.

FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-
796-6570.

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, 2012, through December 31, 
2012. 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.

[[Page 17416]]

   Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From October 1, 2012,
                                            Through December 31, 2012
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        PMA No., Docket No.               Applicant              Trade name                Approval date
----------------------------------------------------------------------------------------------------------------
P110038, FDA-2012-M-1012..........  Bolton Medical Inc...  Relay[supreg]          September 21, 2012.
                                                            Thoracic Stent-Graft
                                                            with Plus Delivery
                                                            System.
P110042, FDA-2012-M-1048..........  Cameron Health, Inc..  Subcutaneous           September 28, 2012.
                                                            Implantable
                                                            Defibrillator (S-
                                                            ICD[supreg]) System.
P100003, FDA-2012-M-1039..........  Globus Medical, Inc..  Secure-C Artificial    September 28, 2012.
                                                            Cervical Disc.
P120005, FDA-2012-M-1049..........  Dexcom, Inc..........  Dexcom G4 PLATINUM     October 5, 2012.
                                                            Continuous Glucose
                                                            Monitoring System.
P120006, FDA-2012-M-1110..........  TriVascular, Inc.....  Ovation Abdominal      October 5, 2012.
                                                            Stent Graft System.
P120007, FDA-2012-M-1066..........  Gen-Probe, Inc.......  APTIMA[supreg] HPV 16  October 12, 2012.
                                                            18/45 Genotype Assay.
P110008, FDA-2012-M-1085..........  Paradigm Spine, LLC..  coflex[supreg]         October 17, 2012.
                                                            Interlaminar
                                                            Technology.
P110039, FDA-2012-M-1084..........  InSightec, Inc.......  InSightec              October 18, 2012.
                                                            ExAblate[supreg]
                                                            System.
P110021, FDA-2012-M-1088..........  Edwards Lifesciences,  Edwards SAPIENTM       October 19, 2012.
                                     LLC.                   Transcatheter Heart
                                                            Valve.
P100040/S008, FDA-2012-M-1109.....  Medtronic Vascular...  Valiant[supreg]        October 26, 2012.
                                                            Thoracic Stent Graft
                                                            with the Captivia
                                                            Delivery System.
P100012, FDA-2012-M-1111..........  NuVasive, Inc........  PCM[supreg] Cervical   October 26, 2012.
                                                            Disc System.
P120002, FDA-2012-M-1183..........  Cordis Corporation...  S.M.A.R.T.[supreg]     November 7, 2012
                                                            CONTROL[supreg] and
                                                            S.M.A.R.T.[supreg]
                                                            Vascular Stent
                                                            Systems..
P100022, FDA-2012-M-1146..........  Cook, Inc............  Zilver PTX Drug-       November 14, 2012.
                                                            Eluting Peripheral
                                                            Stent.
P100047, FDA-2012-M-1184..........  HeartWare, Inc.......  HeartWare[supreg]      November 20, 2012.
                                                            Ventricular Assist
                                                            System.
P120008, FDA-2012-M-1176..........  Abbott Laboratories..  ARCHITECT AFP Assay,   November 28, 2012.
                                                            ARCHITECT AFP
                                                            Calibrators and
                                                            ARCHITECT AFP
                                                            Controls.
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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: March 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06429 Filed 3-20-13; 8:45 am]
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