[Federal Register Volume 71, Number 120 (Thursday, June 22, 2006)]
[Notices]
[Pages 35920-35921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-9898]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2006M-0075, 2006M-0009, 2006M-0014, 2006M-0015, 2006M-
0163]


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 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: Thinh Nguyen, Center for Devices and 
Radiological Health (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2186, ext. 152.

SUPPLEMENTARY INFORMATION:

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 January 1, 2006, through March 31, 
2006. 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 January 1, 2006, through March 31, 2006
------------------------------------------------------------------------
  PMA No./Docket
       No.           Applicant     Trade Name         Approval Date
------------------------------------------------------------------------
P020024/2006M-     AGA Medical   AMPLATZER DUCT             May 14, 2003
 0075               Corp.         OCCULUDER AND
                                  180 DELIVERY
                                  SYSTEM
------------------------------------------------------------------------
P020001/2006M-     Neoventa      STAN S31 FETAL         November 1, 2005
 0009               Medical AB    HEART MONITOR
------------------------------------------------------------------------
P040001/2006M-     St. Francis   X STOP                November 21, 2005
 0014               Medical       INTERSPINOUS
                    Technologie   PROCESS
                    s, Inc.       DECROMPRESSIO
                                  N SYSTEM
------------------------------------------------------------------------
P050009/2006M-     Biomet, Inc.  C2 A-TAPER            December 16, 2005
 0015                             ACETABULAR
                                  SYSTEM
------------------------------------------------------------------------

[[Page 35921]]

 
P050007/2006M-     Abbott        STARCLOSE             December 21, 2005
 0016               Vascular      VASCULAR
                    Devices       CLOSURE
                    (AVD)         SYSTEM
------------------------------------------------------------------------
H040005/2006M-     Karl Storz    KARL STORZ               March 31, 2006
 0163               Endoscopy-    RIGID TTTS
                    America,      FETOSCOPY
                    Inc.          INSTRUMENT
                                  SET WITH 0
                                  AND 12 DEGREE
                                  SCOPE, KARL
                                  STORZ RIGID
                                  TTTS
                                  FETOSCOPY
                                  INSTRUMENT
                                  SET WITH 30
                                  DEGREE SCOPE,
                                  AND KARL
                                  STORZ SEMI-
                                  RIGID TTTS
                                  FETOSCOPY
                                  INSTRUMENT
                                  SET
------------------------------------------------------------------------

II. Electronic Access

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

    Dated: June 13, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-9898 Filed 6-21-06; 8:45 am]
BILLING CODE 4160-01-S