ALBUMIN COATED DEBAKEY(R) VASCULAR(R) VASCULAR-II

FDA Premarket Approval P920027

Pre-market Approval Supplement Details

• Device: ALBUMIN COATED DEBAKEY(R) VASCULAR(R) VASCULAR-II
• Generic Name: Graft, Vascular, Synthetic/biologic Composite
• Applicant: C.R. Bard, Inc.
• Date Received: 1992-06-03
• Decision Date: 1994-10-21
• Notice Date: 1997-05-27
• PMA: P920027
• Supplement: S
• Product Code: MAL
• Docket Number: 97M-0203
• Advisory Committee: Cardiovascular
• Expedited Review: No
• Combination Product: No
• Applicant Address: C.R. Bard, Inc. 129 Concord Rd., Bldg.#4 billerica, MA 01821

Supplemental Filings

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Supplement Number	Date	Supplement Type
P920027		Original Filing