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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 NumberS008
Date Received03/13/2012
Decision Date04/18/2012
Conversion Date 08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MANUFACTURING SITES LOCATED AT FLEXMEDICAL, IN TIJUANA, BAJA CALIFORNIA, MEXICO AND ADVANCED BIOHEALING INC., IN SAN DIEGO, CALIFORNIA.
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