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 Department of Health and Human Services 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]
 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.


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 
                    ( print 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 § 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 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 DateP020026/2003M-0172
Cordis Corp.
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM
April 24, 2003P020023/2004M-0309
Q-Med Scandinavia, Inc.
RESTYLANE INJECTABLE GEL
December 12, 2003P030044/2004M-0433
DakoCytomation California, Inc.
DAKOCYTOMATION EGFR PHARMDX
February 12, 2004P030024/2004M-0341
Ortho-Clinical Diagnostics, Inc.
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
March 4, 2004P030026/2004M-0356
Ortho-Clinical Diagnostics, Inc.
VITROS IMMUNODIAGOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR
March 4, 2004P030025/2004M-0403
Boston Scientific Corp.
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
March 4, 2004P020030/2004M-0310
Ela Medical, Inc.
STELID II/STELIX/STELIX II ENDOCARDIAL PACING LEAD
June 17, 2004P970043 (S015)/2004M-0312
Alcon Laboratories, Inc.
LADARVISION 4000 EXCIMER LASER SYSTEM
June 29, 2004P030054/2004M-0313
St. Jude Medical, Inc.
ST. JUDE MEDICAL EPIC HF SYSTEM
June 30, 2004P040008/2004M-0342
bioMerieux, Inc.
VIDAS TPSA ASSAY
July 8, 2004P030012/2004M-0323
R2 Technology, Inc.
IMAGECHECKER CT CAD SOFTWARE SYSTEM (MODEL LN-1000)
July 8, 2004P010061/2004M-0345
Photo Cure, ASA
CURELIGHT BROADBAND (MODEL CURELIGHT 01)
July 28, 2004P030050/2004M-0350
Dermik Laboratories
SCULPTRA
August 3, 2004P030010/2004M-0387
Siemens Medical Solutions USA, Inc.
SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
August 20, 2004H030009/2004M-0415
Synthes (USA)
VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR)
August 24, 2004P040012/2004M-0388
Guidant Corp.
ACULINK CAROTID STENT SYSTEM & RX ACCULINK CAROTID STENT SYSTEM
August 30, 2004P010012 (S026)/2004M-0430
Guidant Corp.
CONTAK CD (MODEL 1823), CONTAK CD 2 (MODELS H115 & H119), RENEWAL (MODEL H135), RENEWAL 3 (MODELS H170, H175, H177, & H179)
September 14, 2004
 
 
 II. Electronic Access Persons with access to the Internet may obtain the documents at 
                    *http://www.fda.gov/​cdrh/​pmapage.html*. 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] BILLING CODE 4160-01-S