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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 GELSOFT(TM) VASCULAR GRAFT
Generic NameGRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
Regulation Number870.3450
ApplicantCarbomedics, Inc.
1300-D E. Anderson Ln.
Austin, TX 78752
PMA NumberP890045
Supplement NumberS001
Date Received07/08/1993
Decision Date07/05/1995
Reclassified Date05/10/2001
Product Code MAL 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPLYING THE GELATIN COATING TO THE VASCUSOFT, A DIFFERENT SUBSTRATE GRAFT.THE MODIFIED DEVICE WILL BE MARKETED UNDER TRADE NAME:VASCUTEK GELSOFT VASCULAR GRAFT
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