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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
Generic NameDressing, wound and burn, interactive
ApplicantSHIRE REGENERATIVE MEDICINE
11095 TORREYANA ROAD
SAN DIEGO, CA 92121
PMA NumberP000036
Supplement NumberS002
Date Received03/05/2002
Decision Date03/19/2002
Conversion Date 08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE CAUTION STATEMENT IN THE DIRECTIONS FOR USE FROM "DO NOT USE DERMAGRAFT AFTER THE EXPIRATION DATE" TO "DO NOT USE DERMAGRAFT AFTER THE EXPIRATION DATE INDICATED ON THE LABELED UNIT CARTON."
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