[Federal Register Volume 72, Number 109 (Thursday, June 7, 2007)]
[Notices]
[Pages 31586-31587]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11002]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2007M-0109, 2007M-0006, 2007M-0007, 2007M-0032, 2007M-
0049, 2007M-0038, 2007M-0058, 2007M-0086, 2007M-0107, 2007M-0084, 
2007M-0108]


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: Thinh Nguyen, Center for Devices and 
Radiological Health (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-4010, 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

[[Page 31587]]

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, 2007, through March 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 January 1, 2007, through March 31, 2007
------------------------------------------------------------------------
 PMA No./Docket                                               Approval
      No.           Applicant            Trade Name             Date
------------------------------------------------------------------------
P040051/2007M-   Stelkast Co.    STELKAST SURPASS           May 12, 2006
 0109                             ACETABULAR SYSTEM
------------------------------------------------------------------------
P050037/2007M-   Bioform         RADIESSE 1.3 CC AND 0.3    December 22,
 0006             Medical, Inc.   CC                         2006
------------------------------------------------------------------------
P050052/2007M-   Bioform         RADIESSE 1.3 CC AND 0.3    December 22,
 0007             Medical, Inc.   CC                         2006
------------------------------------------------------------------------
P050018/2007M-   Angioscore,     ANGIOSCULPT SCORING        January 8,
 0032             Inc.            BALLOON CATHETER           2007
------------------------------------------------------------------------
P060001/2007M-   EV3, Inc.       PROTEGE GPS AND PROTEGE    January 24,
 0049                             RX CAROTID STENT SYSTEMS   2007
------------------------------------------------------------------------
H060004/2007M-   Fujirebio       FUJIREBIO MESOMARK ASSAY   January 24,
 0038             Diagnostics,                               2007
                  Inc.
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P050007(S1)/     Abbott          STARCLOSE VASCULAR         February 2,
 2007M-0058       Vascular        CLOSURE SYSTEM             2007
                  Devices
------------------------------------------------------------------------
P050013/2007M-   Tissue Seal,    HISTOACRYL & HISTOACRYL    February 16,
 0086             LLC.            BLUE TOPICAL SKIN          2007
                                  ADHESIVE
------------------------------------------------------------------------
P980022(S15)/    Medtronic       GUARDIAN RT & PARADIGM     March 8,
 2007M-0107       Minimed         REAL-TIME CONTIUOUS        2007
                                  GLUCOSE MONITORING
                                  SYSTEMS
------------------------------------------------------------------------
P050053/2007M-   Medtronic       INFUSE BONE GRAFT          March 9,
 0084             Sofamor Danek                              2007
                  USA, Inc.
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P060019/2007M-   Irvine          IBI THERAPY COOL PATH      March 16,
 0108             Biomedical,     ABLATION CATHETER & IBI-   2007
                  Inc.            1500T9 RF ABLATION
                                  GENERATOR
------------------------------------------------------------------------

II. Electronic Access

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

    Dated: May 24, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-11002 Filed 6-6-07; 8:45 am]
BILLING CODE 4160-01-S