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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 NumberS001
Date Received04/08/1997
Decision Date10/17/1997
Conversion Date 08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the new indication of partial thickness burns that are mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting.
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