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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.
 
DeviceDARDIK BIOGRAFT(R) MOD. HUMAN UMBILICAL VEIN GRAFT
Generic NameTissue graft of 6mm and greater
ApplicantSynovis Surgical Innovations
2575 University Ave. W.
St. Paul, MN 55114
PMA NumberP780002
Supplement NumberS012
Date Received09/08/1995
Decision Date11/24/1995
Withdrawal Date12/13/2007
Product Code LXA 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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