Food and Drug Administration, HHS.
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.
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.Start Further Info
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.End Further Info End Preamble Start Supplemental Information
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.Start Printed Page 11735
|PMA No./Docket No.||Applicant||TRADE NAME||Approval Date|
|P070015 FDA-2008-M-0535||Abbott Vascular Inc.||XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM & PROMUS ELUTING CORONARY STENT SYSTEM||July 2, 2008|
|P030025 (S28) FDA-2008-M-0547||Boston Scientific Corp.||TAXUS EXPRESS2 PACLITAXEL ELUTING CORONARY STENT SYSTEM||September 24, 2008|
|P080004 FDA-2008-M-0536||Hoya Surgical Optics, Inc.||HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS||September 26, 2008|
|H070004 FDA-2008-M-0563||Levitronix, LLC||LEVITRONIX CENTRIMAG RIGHT VENTRICULAR ASSIST SYSTEM (RVAS)||October 7, 2008|
|P060008 FDA-2008-M-0593||Boston Scientific Corp.||TAXUS LIBERTE' PACLITAXEL ELUTING CORONARY STENT SYSTEM||October 10, 2008|
|P050029 FDA-2008-M-0601||Stereotaxis, Inc.||HELIOS II ABLATION CATHETER||October 10, 2008|
|H040004 FDA-2008-M-0562||Medtronic Sofamor Danek USA, Inc.||INFUSE/MASTERGRAFT POSTEROLATERAL REVISION DEVICE||October 10, 2008|
|P050019 FDA-2008-M-0596||Boston Scientific Corp.||CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS||October 23, 2008|
|H060002 FDA-2008-M-0579||Spiration, Inc.||IBV VALVE SYSTEM||October 24, 2008|
|P060025 FDA-2008-M-0594||ATS Medical, Inc.||ATS 3F AORTIC BIOPROSTHESIS||October 30, 2008|
|P080011 FDA-2008-M-0608||Coopervision Manufacturing, Ltd.||BIOFINITY COMFILCON A (EXTENDED WEAR SOFT CONTACT LENSES)||November 19, 2008|
|P080007 FDA-2008-M-0645||Bard Peripheral Vascular Inc.||BARD E-LUMINEXX VASCULAR STENT||December 4, 2008|
|P060006 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.Start Signature
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]
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