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Circulatory System Devices Panel Meeting Summary for
September 10-11, 2001

A meeting of the Circulatory System Devices Panel was held on September 10-11, 2001. On September 10, the Panel discussed, made recommendations, and voted on a premarket approval application for AGA Medical's Amplatzer® Septal Occlusion Device (P000039). The device is a septal occluder used in the closure of atrial septal defects and closure of the fenestration following a Fenestrated Fontan procedure. Following presentations by the sponsor and the FDA, and after questioning the sponsor and deliberating, the Panel voted (10-0) that the application be found 'approvable with conditions'. The Panel's conditions included recommendations for post-market study of the device and labeling modifications.

Subsequently, the Panel discussed, made recommendations, and voted on a premarket approval application for NMT Medical's CardioSEAL®Septal Occlusion System with QwikLoad™. The device is a septal occluder used in the treatment of complex ventricular septal defects. Following presentations by the sponsor and the FDA, and after questioning the sponsor and deliberating, the Panel voted (9-1) that the application be found 'approvable with conditions'. The Panel's conditions included recommendations for post-market study of the device, augmented training procedures for physicians implanting the device, and labeling modifications.

On September 11, the Panel discussed, made recommendations, and voted on a premarket approval application for CryoLife's BioGlue®Surgical Sealant (P010003). The device is an adhesive/sealant composed of bovine serum albumin and glutaraldehyde, for adjunctive use with standard cardiac and vascular repair techniques. Following presentations by the sponsor and the FDA, and after questioning the sponsor and deliberating, the Panel voted (4-0) that the application be found 'approvable with conditions'. The sole condition identified by the Panel related to a recommendation about removal of statements made in the sponsor's application.

At that point, the audience was notified that the Federal Government was closing due to national security events and the meeting was adjourned. Another application was scheduled to be considered, Cohesion Technologies CoSeal®Surgical Sealant (P010022).

Contact: Megan Moynahan, Executive Secretary,
(301) 443-8517, ext. 180, mbm@cdrh.fda.gov

Transcripts may be purchased from: (written requests only)
Neal R. Gross and Company, Inc.
1323 Rhode Island Avenue, NW
Washington, D.C. 20005
(202) 234-4433 (Voice); (202) 387-7330 (FAX)
Or
Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20851
(301) 827-6500 (voice), (301) 332-1726 (fax)

Under normal circumstances, panel summary minutes are available 60-90 days post meeting. Summaries are also available on the CDRH web site:
http://www.fda.gov/cdrh/panelmtg.html

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Uploaded September 14, 2001

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