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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.
 
DeviceN.C.G.T. GRAFT
Generic NameTissue graft of 6mm and greater
ApplicantSt. Jude Medical, Inc.
177 E. County Rd. B E.
St Paul, MN 55117
PMA NumberP800058
Supplement NumberS005
Date Received09/22/1986
Decision Date07/30/1987
Withdrawal Date12/03/2007
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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