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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.
 
DeviceTRANSCYTE/HUMAN FIBROBLAST DERIVED TEMPORARY SKIN SUBSTITUTE
Generic NameDressing, wound and burn, interactive
ApplicantSHIRE REGENERATIVE MEDICINE
11095 TORREYANA ROAD
SAN DIEGO, CA 92121
PMA NumberP960007
Supplement NumberS015
Date Received06/26/2001
Decision Date08/30/2001
Conversion Date 08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AMENDED LABELING TO INCLUDE INFORMATION REGARDING THE RESULTS OF TESTING THE DONOR MOTHER'S SERA FOR VIRUSES AND OTHER INFECTIOUS AGENTS.
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