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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.
 
DeviceDERMAGRAFT-TC(TM)
Generic NameDressing, wound and burn, interactive
ApplicantSHIRE REGENERATIVE MEDICINE
11095 TORREYANA ROAD
SAN DIEGO, CA 92121
PMA NumberP960007
Supplement NumberS003
Date Received10/22/1997
Decision Date11/24/1997
Conversion Date 08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a change of Dermagraft-TC storage conditions to include -20C frost-free freezers.
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