[Federal Register: December 15, 2004 (Volume 69, Number 240)]
[Page 75073-75075]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket Nos. 2003M-0172, 2004M-0309, 2004M-0433, 2004M-0341, 2004M-
0356, 2004M-0403, 2004M-0310, 2004M-0312, 2004M-0313, 2004M-0342, 
2004M-0323, 2004M-0345, 2004M-0350, 2004M-0387, 2004M-0415, 2004M-0388, 
and 2004M-0430]

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.


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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov. FDA believes that 

this procedure expedites public

[[Page 75074]]

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 
    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 July 1, 2004, through September 30, 
2004. 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 July 1, 2004, through September 30, 2004
 PMA No./Docket
       No.            Applicant           Trade Name       Approval Date
P020026/2003M-    Cordis Corp.      CYPHER SIROLIMUS-      April 24,
 0172                                ELUTING CORONARY       2003
                                     STENT ON THE RAPTOR
                                     DELIVERY SYSTEM OR
                                     RAPTORRAIL RAPID
                                     EXCHANGE DELIVERY
P020023/2004M-    Q-Med             RESTYLANE INJECTABLE   December 12,
 0309              Scandinavia,      GEL                    2003
P030044/2004M-    DakoCytomation    DAKOCYTOMATION EGFR     February 12,
 0433              California,       PHARMDX                2004
P030024/2004M-    Ortho-Clinical    VITROS                 March 4, 2004
 0341              Diagnostics,      IMMUNODIAGNOSTIC
                   Inc.              PRODUCTS ANTI-HBC
                                     REAGENT PACK AND
P030026/2004M-    Ortho-Clinical    VITROS                 March 4, 2004
 0356              Diagnostics,      IMMUNODIAGOSTIC
                   Inc.              PRODUCTS ANTI-HBC
                                     IGM REAGENT PACK AND
P030025/2004M-    Boston            TAXUS EXPRESS2         March 4, 2004
 0403              Scientific        PACLITAXEL-ELUTING
                   Corp.             CORONARY STENT
                                     SYSTEM (MONORAIL AND
P020030/2004M-    Ela Medical,      STELID II/STELIX/      June 17, 2004
 0310              Inc.              STELIX II
                                     ENDOCARDIAL PACING
P970043 (S015)/   Alcon             LADARVISION 4000       June 29, 2004
 2004M-0312        Laboratories,     EXCIMER LASER SYSTEM
P030054/2004M-    St. Jude          ST. JUDE MEDICAL EPIC  June 30, 2004
 0313              Medical, Inc.     HF SYSTEM
P040008/2004M-    bioMerieux, Inc.  VIDAS TPSA ASSAY       July 8, 2004
P030012/2004M-    R2 Technology,    IMAGECHECKER CT CAD    July 8, 2004
 0323              Inc.              SOFTWARE SYSTEM
                                     (MODEL LN-1000)
P010061/2004M-    Photo Cure, ASA   CURELIGHT BROADBAND    July 28, 2004
 0345                                (MODEL CURELIGHT 01)
P030050/2004M-    Dermik            SCULPTRA               August 3,
 0350              Laboratories                             2004
P030010/2004M-    Siemens Medical   SIEMENS MAMMOMAT       August 20,
 0387              Solutions USA,    NOVATIONDR FULL        2004
                   Inc.              FIELD DIGITAL
                                     MAMMOGRAPHY SYSTEM
H030009/2004M-    Synthes (USA)     VERTICAL EXPANDABLE    August 24,
 0415                                PROSTHETIC TITANIUM    2004
                                     RIB (VEPTR)
P040012/2004M-    Guidant Corp.     ACULINK CAROTID STENT  August 30,
 0388                                SYSTEM & RX ACCULINK   2004
                                     CAROTID STENT SYSTEM
P010012 (S026)/   Guidant Corp.     CONTAK CD (MODEL       September 14,
 2004M-0430                          1823), CONTAK CD 2     2004
                                     (MODELS H115 &
                                     H119), RENEWAL
                                     (MODEL H135),
                                     RENEWAL 3 (MODELS
                                     H170, H175, H177, &

[[Page 75075]]

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 

    Dated: December 3, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-27387 Filed 12-14-04; 8:45 am]