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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 NumberS016
Date Received11/05/2001
Decision Date12/26/2001
Conversion Date 08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE CEASING OF ENROLLMENT OF NEW PATIENTS IN THE POST-MARKET APPROVAL STUDY: TC-01-07-0597 "AN OPEN LABEL STUDY TO EVALUATE THE INCIDENCE OF WOUND INFECTION IN PATIENTS REQUIRING A TEMPORARY COVERING FOR EXCISED BURN WOUNDS"
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