Document ID: FDA-2008-M-0207-0003
Agency: fda
Document Type: Notice
Title: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Posted Date: 2008-09-26T04:00Z

[Federal Register: September 26, 2008 (Volume 73, Number 188)]
[Notices]               
[Page 55852-55853]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se08-68]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2008-M-0207, FDA-2008-M-0243, FDA-2008-M-0244, FDA-
2008-M-0283, FDA-2008-M-0335, FDA-2008-M-0311, FDA-2008-M-0342, FDA-
2008-M-0378]

 
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 (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-4010.

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

[[Page 55853]]

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 April 1, 2008, through June 30, 2008. 
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, 2008, through June 30, 2008
------------------------------------------------------------------------
   PMA No./                                                    Approval
  Docket No.       Applicant              TRADE NAME             Date
------------------------------------------------------------------------
P050020        Abbott Diabetes    FREESTYLE NAVIGATOR         March 12,
FDA-2008-M-02   Care, Inc.         CONTINUOUS GLUCOSE          2008
 07                                MONITORING SYSTEM
------------------------------------------------------------------------
P010012        Guidant Corp.      Contak Renewal 3 AVT        March 13,
 (S037)                            system & contak reviewal    2008
FDA-2008-M-02                      3AVT HE System
 43
------------------------------------------------------------------------
P070027        Medtronic          The talent abdominal stent  April 15,
FDA-2008-M-02   Vascular           graft system                2008
 44
------------------------------------------------------------------------
P060040        Thoratec Corp.     Thoratec Heartmate II Left  April 21,
FDA-2008-M-02                      ventricular assist          2008
 83
------------------------------------------------------------------------
P070008        Biotronik, Inc.    Stratos LV CRT-P & stratos  May 12,
FDA-2008-M-03                      LV-T CRT-P, corox OTW BP    2008
 35                                lead & corox OTW-s bp
                                   lead
------------------------------------------------------------------------
P070016        Cook, Inc.         Zenith TX2 Thoracic TAA     May 21,
FDA-2008-M-03                      endovascular graft with     2008
 11                                the H&LB One-shot
                                   introduction system
------------------------------------------------------------------------
P070007        Medtronic          Talent Thoracic Stent       June 5,
FDA-2008-M-03   Vascular           Graft System                2008
 42
------------------------------------------------------------------------
H070003        Synapse            NeuRx RA/4                  June 17,
FDA-2008-M-03   Biomedical, Inc.                               2008
 78
------------------------------------------------------------------------

II. Electronic Access

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

    Dated: September 12, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-22668 Filed 9-25-08; 8:45 am]

BILLING CODE 4160-01-S