Document ID: FDA-2013-M-0463-0002
Agency: fda
Document Type: Notice
Title: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Posted Date: 2013-08-19T04:00Z

[Federal Register Volume 78, Number 160 (Monday, August 19, 2013)]
[Notices]
[Pages 50422-50423]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20085]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-M-0462, FDA-2013-M-0463, FDA-2013-M-0464, FDA-
2013-M-0549, FDA-2013-M-0592, FDA-2013-M-0594, FDA-2013-M-0595, FDA-
2013-M-0709, FDA-2013-M-0724, FDA-2013-M-0738, and FDA-2013-M-0758]

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: 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.

[[Page 50423]]

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, 2013, through June 30, 2013. 
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, 2013, Through
                                                  June 30, 2013
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     PMA No., Docket No.             Applicant                  Trade name                   Approval date
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P120016, FDA-2013-M-0592.....  Cardiva Medical, Inc.  VASCADE Vascular Closure        January 31, 2013.
                                                       System (VCS).
P070026/S004, FDA-2013-M-0462  DePuy Orthopaedics,    DuPuy Ceramax Ceramic Total     April 2, 2013.
                                Inc..                  Hip System.
P960043/S080, FDA-2013-M-0464  Abbott Vascular......  PERCLOSE PROGLIDE Suture        April 15, 2013.
                                                       Mediated Closure System.
P980040/S039, FDA-2013-M-0463  Abbott Medical         TECNIS Toric 1-Piece            April 15, 2013.
                                Optics, Inc..          Intraocular Lens (IOL) and
                                                       the TECNIS Toric Calculator
                                                       System.
P080009, FDA-2013-M-0549.....  Ethicon Endo-Surgery,  SEDASYS Computer-Assisted       May 3, 2013.
                                Inc..                  Personalized Sedation System.
P120019, FDA-2013-M-0594.....  Roche Molecular        COBAS EGFR Mutation Test......  May 14, 2013.
                                Systems, Inc..
P080003/S001, FDA-2013-M-0595  Hologic, Inc.........  Selenia Dimensions 3D System..  May 16, 2013.
P030002/S027, FDA-2013-M-0724  Bausch+Lomb, Inc.....  TRULIGN Toric Posterior         May 20, 2013.
                                                       Chamber Intraocular Lens.
P120014, FDA-2013-M-0709.....  bioM[eacute]rieux,     THxID BRAF Kit for use on the   May 29, 2013.
                                Inc..                  ABI 7500 Fast DX Real-Time
                                                       PCR Instrument.
P060028, FDA-2013-M-0738.....  Mentor Worldwide LLC.  MEMORYSHAPE Breast Implants...  June 14, 2013.
P120012, FDA-2013-M-0758.....  Abbott Molecular,      Abbott RealTime HCV Genotype    June 20, 2013.
                                Inc..                  II, Abbott RealTime HCV
                                                       Genotype II Control Kit, and
                                                       Uracil-N-Glycosylase (UNG).
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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: August 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20085 Filed 8-16-13; 8:45 am]
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