Document ID: FDA-2012-M-0371-0003
Agency: fda
Document Type: Notice
Title: Safety and Effectiveness Summaries for Premarket Approval Applications; Availability: Medical Devices
Posted Date: 2012-10-04T04:00Z

[Federal Register Volume 77, Number 193 (Thursday, October 4, 2012)]
[Notices]
[Pages 60704-60705]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24479]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2012-M-0371, FDA-2012-M-0372, FDA-2012-M-0373, FDA-
2012-M-0390, FDA-2012-M-0407, FDA-2012-M-0562, and FDA-2012-M-0638]

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

[[Page 60705]]

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 April 1, 2012, through June 30, 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.

Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From April 1, 2012, Through
                                                  June 30, 2012
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        PMA No., Docket No.               Applicant                Trade name                Approval date
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P020018/S040, FDA-2012-M-0371.....  Cook, Inc............  Zenith[supreg] Fenestrated  April 4, 2012.
                                                            AAA Endovascular Graft
                                                            (with the adjunctive
                                                            Zenith Alignment Stent).
P110029, FDA-2012-M-0372..........  Abbot Laboratories...  ARCHITECT HBsAg             April 12, 2012.
                                                            Qualitative, ARCHITECT
                                                            HBsAg Qualitative
                                                            Confirmatory, ARCHITECT
                                                            HBsAg Qualitative
                                                            Confirmatory Manual
                                                            Diluent, ARCHITECT HBsAg
                                                            Qualitative Calibrators,
                                                            and ARCHITECT HBsAg
                                                            Qualitative Controls.
P110004, FDA-2012-M-0407..........  Medinol Ltd..........  Presillion\TM\ plus CoCr    April 12, 2012.
                                                            Coronary Stent on RX
                                                            System.
P110035, FDA-2012-M-0373..........  Boston Scientific      Epic\TM\ Vascular Self-     April 13, 2012.
                                     Corp.                  Expanding Stent System.
P090015, FDA-2012-M-0390..........  Leica Biosystems.....  BOND\TM\ ORACLE\TM\ HER2    April 18, 2012.
                                                            IHC System.
P110010/S001, FDA-2012-M-0562.....  Boston Scientific      PROMUS[supreg] Element\TM\  June 1, 2012.
                                     Corp.                  Plus Everolimus-Eluting
                                                            Platinum Chromium
                                                            Coronary Stent System
                                                            (Monorail\TM\ and Over-
                                                            the-Wire).
P090026, FDA-2012-M-0638..........  Beckman Coulter, Inc.  Access[supreg]              June 14, 2012.
                                                            Hybritech[supreg] p2PSA
                                                            on the Access Immunoassay
                                                            Systems.
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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 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-24479 Filed 10-3-12; 8:45 am]
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