Document ID: FDA-2008-M-0535-0001
Agency: fda
Document Type: Notice
Title: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Posted Date: 2009-03-19T04:00Z

[Federal Register: March 19, 2009 (Volume 74, Number 52)]
[Notices]               
[Page 11734-11735]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19mr09-56]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2008-M-0535, FDA-2008-M-0547, FDA-2008-M-0536, FDA-
2008-M-0563, FDA-2008-M-0593, FDA-2008-M-0601, FDA-2008-M-0562, FDA-
2008-M-0596, FDA-2008-M-0579, FDA-2008-M-0594, FDA-2008-M-0608, FDA-
2008-M-0645, FDA-2008-M-0646]

 
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 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, 2008, through December 31, 
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.

[[Page 11735]]

  Table 1--List of Safety and Effectiveness Summaries for Approved PMAs
     Made Available From October 1, 2008, through December 31, 2008.
------------------------------------------------------------------------
PMA No./Docket                                                 Approval
      No.          Applicant             TRADE NAME              Date
------------------------------------------------------------------------
P070015         Abbott          XIENCE V EVEROLIMUS ELUTING  July 2,
FDA-2008-M-053   Vascular Inc.   CORONARY STENT SYSTEM &      2008
 5                               PROMUS ELUTING CORONARY
                                 STENT SYSTEM
------------------------------------------------------------------------
P030025 (S28)    Boston         TAXUS EXPRESS2 PACLITAXEL    September
FDA-2008-M-054   Scientific      ELUTING CORONARY STENT       24, 2008
 7               Corp.           SYSTEM
------------------------------------------------------------------------
P080004         Hoya Surgical   HOYA ISPHERIC MODEL YA-60BB  September
FDA-2008-M-053   Optics, Inc.    INTRAOCULAR LENS             26, 2008
 6
------------------------------------------------------------------------
H070004         Levitronix,     LEVITRONIX CENTRIMAG RIGHT   October 7,
FDA-2008-M-056   LLC             VENTRICULAR ASSIST SYSTEM    2008
 3                               (RVAS)
------------------------------------------------------------------------
P060008         Boston          TAXUS LIBERTE' PACLITAXEL    October 10,
FDA-2008-M-059   Scientific      ELUTING CORONARY STENT       2008
 3               Corp.           SYSTEM
------------------------------------------------------------------------
P050029         Stereotaxis,    HELIOS II ABLATION CATHETER  October 10,
FDA-2008-M-060   Inc.                                         2008
 1
------------------------------------------------------------------------
H040004         Medtronic        INFUSE/MASTERGRAFT          October 10,
FDA-2008-M-056   Sofamor Danek   POSTEROLATERAL REVISION      2008
 2               USA, Inc.       DEVICE
------------------------------------------------------------------------
P050019         Boston          CAROTID WALLSTENT MONORAIL   October 23,
FDA-2008-M-059   Scientific      ENDOPROSTHESIS               2008
 6               Corp.
------------------------------------------------------------------------
H060002         Spiration,      IBV VALVE SYSTEM             October 24,
FDA-2008-M-057   Inc.                                         2008
 9
------------------------------------------------------------------------
P060025         ATS Medical,    ATS 3F AORTIC BIOPROSTHESIS  October 30,
FDA-2008-M-059   Inc.                                         2008
 4
------------------------------------------------------------------------
P080011         Coopervision     BIOFINITY COMFILCON A       November
FDA-2008-M-060   Manufacturing   (EXTENDED WEAR SOFT          19, 2008
 8               , Ltd.          CONTACT LENSES)
------------------------------------------------------------------------
P080007         Bard             BARD E-LUMINEXX VASCULAR    December 4,
FDA-2008-M-064   Peripheral      STENT                        2008
 5               Vascular Inc.
------------------------------------------------------------------------
P060006          Boston         BOSTON SCIENTIFIC EXPRESS     December
FDA-2008-M-064   Scientific      SD RENAL MONORAIL            11, 2008
 6               Corp.           PREMOUNTED STENT SYSTEM
------------------------------------------------------------------------

II. Electronic Access

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

    Dated: March 10, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E9-6026 Filed 3-18-09; 8:45 am]

BILLING CODE 4160-01-S