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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVASCUTEK GELSEAL(TM) VASCULAR GRAFT
Generic NameGRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
Regulation Number870.3450
ApplicantCARBOMEDICS, INC.
1300-D EAST ANDERSON LN.
AUSTIN, TX 78752
PMA NumberP890045
Supplement NumberS005
Date Received03/31/1994
Decision Date04/13/1995
Reclassified Date 05/10/2001
Product Code MAL 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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