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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameALBUMIN COATED DEBAKEY(R) VASCULAR(R) VASCULAR-II
Classification Namegraft, vascular, synthetic/biologic composite
Regulation Number870.3450
ApplicantC.R. BARD, INC.
PMA NumberP920027
Date Received06/03/1992
Decision Date10/21/1994
Reclassified Date 05/11/2001
Product Code
MAL[ Registered Establishments with MAL ]
Docket Number 97M-0203
Notice Date 05/27/1997
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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