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Notice

Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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.

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FOR FURTHER INFORMATION CONTACT:

Samie Allen, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4013.

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SUPPLEMENTARY INFORMATION:Start Printed Page 30951

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, 2007, through December 31, 2007. 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 October 1, 2007, through December 31, 2007.

PMA No./Docket No.ApplicantTRADE NAMEApproval Date
P000009 (S4)/2007M-0408Biotronik, Inc.TACHOS DR ATRIAL TX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD SYSTEMSeptember 9, 2002
P060031/2007M-0467Bio-Rad LaboratoriesBIO-RAD MONOLISA ANTI-HBC EIAApril 27, 2007
P060005/2007M-0409Siemens Medical Solutions DiagnosticsIMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA ASSAYSMay 11, 2007
P060017/2007M-0413Veridex, LLCGENESEARCH BREAST LYMPH NODE (BLN) ASSAYJuly 16, 2007
P040040/2007M-0446AGA Medical Corp.AMPLATZER MUSCULAR VSDSeptember 7, 2007
P070009/2007M-0380Obtech Medical GMBHREALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-XSeptember 28, 2007
P070012/2007M-0411Medtronic VascularEXPONENT SELF-EXPANDING CAROTIC STENT SYSTEM WITH OVER THE WIRE OR RAPID EXHANGE DELIVERY SYSTEMOctober 23, 2007
P060038/2007M-0410Carbomedics, Inc.MITROFLOW AORTIC PERICARDIAL HEART VALVEOctober 23, 2007
H990002/2007M-0415Genzyme BiosurgeryEPICEL (CULTURED EPIDERMAL AUTOGRAFTS)October 25, 2007
P060035/2007M-0447Abbott LaboratoriesARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLSNovember 6, 2007

II. Electronic Access

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

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Dated: May 16, 2008.

Daniel G. Schultz,

Director, Center for Devices and Radiological Health.

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[FR Doc. E8-12012 Filed 5-28-08; 8:45 am]

BILLING CODE 4160-01-S