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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameGELSEAL TM TRIAXIAL VASCULAR GRAFT
Classification Namegraft, vascular, synthetic/biologic composite
Generic Namevascular graft
Regulation Number870.3450
ApplicantCARBOMEDICS, INC.
PMA NumberP890045
Date Received08/21/1989
Decision Date01/11/1993
Reclassified Date 05/10/2001
Product Code
MAL[ Registered Establishments with MAL ]
Docket Number 93M-0023
Notice Date 05/03/1993
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S003 S005 S006 
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