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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]
 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 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 § 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.
                    ( print 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 No.
Applicant
TRADE NAME
Approval DateP070015
                             FDA-2008-M-0535
Abbott Vascular Inc.
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM & PROMUS ELUTING CORONARY STENT SYSTEM
July 2, 2008P030025 (S28)
                             FDA-2008-M-0547
Boston Scientific Corp.
TAXUS EXPRESS2 PACLITAXEL ELUTING CORONARY STENT SYSTEM
September 24, 2008P080004
                             FDA-2008-M-0536
Hoya Surgical Optics, Inc.
HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS
September 26, 2008H070004
                             FDA-2008-M-0563
Levitronix, LLC
LEVITRONIX CENTRIMAG RIGHT VENTRICULAR ASSIST SYSTEM (RVAS)
October 7, 2008P060008
                             FDA-2008-M-0593
Boston Scientific Corp.
TAXUS LIBERTE' PACLITAXEL ELUTING CORONARY STENT SYSTEM
October 10, 2008P050029
                             FDA-2008-M-0601
Stereotaxis, Inc.
HELIOS II ABLATION CATHETER
October 10, 2008H040004
                             FDA-2008-M-0562
Medtronic Sofamor Danek USA, Inc.
INFUSE/MASTERGRAFT POSTEROLATERAL REVISION DEVICE
October 10, 2008P050019
                             FDA-2008-M-0596
Boston Scientific Corp.
CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS
October 23, 2008H060002
                             FDA-2008-M-0579
Spiration, Inc.
IBV VALVE SYSTEM
October 24, 2008P060025
                             FDA-2008-M-0594
ATS Medical, Inc.
ATS 3F AORTIC BIOPROSTHESIS
October 30, 2008P080011
                             FDA-2008-M-0608
Coopervision Manufacturing, Ltd.
BIOFINITY COMFILCON A (EXTENDED WEAR SOFT CONTACT LENSES)
November 19, 2008P080007
                             FDA-2008-M-0645
Bard Peripheral Vascular Inc.
BARD E-LUMINEXX VASCULAR STENT
December 4, 2008P060006
                             FDA-2008-M-0646
Boston Scientific Corp.
BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM
December 11, 2008
 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