Document ID: FDA-2007-M-0467-0001
Agency: fda
Document Type: Notice
Title: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Posted Date: 2008-05-29T04:00Z

[Federal Register: May 29, 2008 (Volume 73, Number 104)]
[Notices]               
[Page 30950-30951]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29my08-74]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-M-0467] (formerly Docket No. 2007M-0408), [Docket 
No. FDA-2007-M-0481] (formerly Docket No. 2007M-0467), [Docket No. FDA-
2007-M-0480] (formerly Docket No. 2007M-0409), [Docket No. FDA-2007-M-
0472] (formerly Docket No. 2007M-0413), [Docket No. FDA-2007-M-0468] 
(formerly Docket No. 2007M-0446), [Docket No. FDA-2007-M-0494] 
(formerly Docket No. 2007M-0380), [Docket No. FDA-2007-M-0493] 
(formerly Docket No. 2007M-0411), [Docket No. FDA-2007-M-0492] 
(formerly Docket No. 2007M-0410), [Docket No. FDA-2007-M-0490] 
(formerly Docket No. 2007M-0415), [Docket No. FDA-2007-M-0491] 
(formerly Docket No. 2007M-0447]

 
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:  Samie Allen, Center for Devices and 
Radiological Health (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-4013.

SUPPLEMENTARY INFORMATION:

[[Page 30951]]

I. Background

    In the Federal Register of January 30, 1998 (63 FR 4571), FDA 
published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to 
discontinue individual publication of PMA approvals and denials in the 
Federal Register. Instead, the agency now posts this information on the 
Internet on FDA's home page at http://www.fda.gov. FDA believes that 
this procedure expedites public notification of these actions because 
announcements can be placed on the Internet more quickly than they can 
be published in the Federal Register, and FDA believes that the 
Internet is accessible to more people than the Federal Register.
    In accordance with section 515(d)(4) and (e)(2) of the Federal 
Food, Drug, and Cosmetic Act (the 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 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, 2007, through December 31, 
2007. 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 October 1, 2007, through December 31, 2007.
------------------------------------------------------------------------
PMA No./Docket                                                 Approval
      No.          Applicant             TRADE NAME              Date
------------------------------------------------------------------------
P000009 (S4)/   Biotronik,      TACHOS DR ATRIAL TX          September
 2007M-0408      Inc.            IMPLANTABLE CARDIOVERTER     9, 2002
                                 DEFIBRILLATOR ICD SYSTEM
------------------------------------------------------------------------
P060031/2007M-  Bio-Rad         BIO-RAD MONOLISA ANTI-HBC    April 27,
 0467            Laboratories    EIA                          2007
------------------------------------------------------------------------
P060005/2007M-  Siemens         IMMULITE/IMMULITE 1000 &     May 11,
 0409            Medical         IMMULITE 2000 FREE PSA       2007
                 Solutions       ASSAYS
                 Diagnostics
------------------------------------------------------------------------
P060017/2007M-  Veridex, LLC    GENESEARCH BREAST LYMPH      July 16,
 0413                            NODE (BLN) ASSAY             2007
------------------------------------------------------------------------
P040040/2007M-  AGA Medical     AMPLATZER MUSCULAR VSD       September
 0446            Corp.                                        7, 2007
------------------------------------------------------------------------
P070009/2007M-  Obtech Medical  REALIZE ADJUSTABLE GASTRIC   September
 0380            GMBH            BAND MODEL 2200-X            28, 2007
------------------------------------------------------------------------
P070012/2007M-  Medtronic       EXPONENT SELF-EXPANDING      October 23,
 0411            Vascular        CAROTIC STENT SYSTEM WITH    2007
                                 OVER THE WIRE OR RAPID
                                 EXHANGE DELIVERY SYSTEM
------------------------------------------------------------------------
P060038/2007M-  Carbomedics,    MITROFLOW AORTIC             October 23,
 0410            Inc.            PERICARDIAL HEART VALVE      2007
------------------------------------------------------------------------
H990002/2007M-  Genzyme         EPICEL (CULTURED EPIDERMAL   October 25,
 0415            Biosurgery      AUTOGRAFTS)                  2007
------------------------------------------------------------------------
P060035/2007M-  Abbott          ARCHITECT CORE-M REAGENT     November 6,
 0447            Laboratories    KIT/CALIBRATORS/CONTROLS     2007
------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 
http://www.fda.gov/cdrh/pmapage.html.

    Dated: May 16, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-12012 Filed 5-28-08; 8:45 am]

BILLING CODE 4160-01-S