Document ID: FDA-2012-M-0712-0002
Agency: fda
Document Type: Notice
Title: Medical Devices: Safety and Effectiveness Summaries for Premarket Approval Applications
Posted Date: 2013-01-07T05:00Z

[Federal Register Volume 78, Number 4 (Monday, January 7, 2013)]
[Notices]
[Pages 950-951]
From the Federal Register Online via the Government Printing Office [http://www.gpo.gov/]
[FR Doc No: 2013-00004]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2012-M-0712, FDA-2012-M-0713, FDA-2012-M-0734, FDA-
2012-M-0735, FDA-2012-M-0814, FDA-2012-M-0833, FDA-2012-M-0893, FDA-
2012-M-0965, FDA-2012-M-0968, FDA-2012-M-1011, and FDA-2012-M-1013]

Medical Devices; Availability of Safety and Effectiveness 
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 July 1, 2012, through September 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 July 1, 2012, Through
                                               September 30, 2012
----------------------------------------------------------------------------------------------------------------
      PMA No., Docket No.             Applicant            Trade name                   Approval date
----------------------------------------------------------------------------------------------------------------
P980022/S010, FDA-2012-M-0965..  Medtronic MiniMed,  Guardian Telemetered    January 7, 2004.
                                  Inc.                Glucose Monitoring
                                                      System (TGMS).
P000008/S017, FDA-2012-M-1013..  Allergan, Inc.....  LAP-BAND \TM\           February 16, 2011.
                                                      Adjustable Gastric
                                                      Banding System.
P100049, FDA-2012-M-0893.......  Torax Medical, Inc  LINX \TM\ Reflux        March 22, 2012.
                                                      Management System.
P010031/S232, FDA-2012-M-0814..  Medtronic, Inc....  Concerto/Concerto II;   April 4, 2012.
                                                      Consulta; Maximo II;
                                                      and Protecta/Protecta
                                                      XT Families of CRT-Ds.

[[Page 951]]

 
P080030, FDA-2012-M-0712.......  Glaukos Corp......  Glaukos iStent[supreg]  June 25, 2012.
                                                      Trabecular Micro-
                                                      Bypass Stent and
                                                      Inserter.
P110007, FDA-2012-M-0734.......  Abbott Medical      Healon[supreg]          July 2, 2012.
                                  Optics, Inc.        EndoCoat
                                                      OpViscosurgical
                                                      Ophthalmic Device
                                                      (OVD) (3% Sodium
                                                      Hyaluronate).
P110037, FDA-2012-M-0713.......  Roche Molecular     COBAS[supreg]           July 5, 2012.
                                  Systems, Inc.       AmpliPrep/
                                                      COBAS[supreg]
                                                      TaqMan[supreg] CMV
                                                      Test.
P110030, FDA-2012-M-0735.......  QIAGEN Manchester,  therascreen[supreg]     July 6, 2012.
                                  Ltd.                KRAS RGQ PCR Kit.
P110043, FDA-2012-M-0833.......  Abbott Vascular...  Omnilink Elite          July 31, 2012.
                                                      Vascular Balloon-
                                                      Expandable Stent
                                                      System.
P040024/S056, FDA-2012-M-0968..  Medicis Aesthetics  Restylane L Injectable  August 30, 2012.
                                  Holdings, Inc.      Gel.
P110006, FDA-2012-M-1011.......  U-Systems, Inc....  somo-v[supreg]          September 18, 2012
                                                      Automated Breast
                                                      Ultrasound System
                                                      (ABUS).
----------------------------------------------------------------------------------------------------------------

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: December 31, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-00004 Filed 1-4-13; 8:45 am]
BILLING CODE 4160-01-P