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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 Rd.
San Diego, CA 92121
PMA NumberP000036
Supplement NumberS011
Date Received04/23/2012
Decision Date09/05/2012
Conversion Date08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE QUALIFICATION OF AN ALTERNATE SUPPLIER FOR A CRITICAL DEVICE COMPONENT.
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