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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 (HUMAN FIBROBLAST-DERIVED DERMAL SUBSTITUTE)
Generic NameDressing, wound and burn, interactive
ApplicantShire Regenerative Medicine
11095 Torreyana Rd.
San Diego, CA 92121
PMA NumberP000036
Supplement NumberS017
Date Received04/24/2013
Decision Date05/23/2013
Conversion Date08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
QUALIFICATION OF ADDITIONAL SEEDING VESSELS, AND PROPOSED A CHANGE IN THE TYPE OF MATERIAL USED FOR THE TUBING AND MANIFOLD ASSEMBLY CONNECTOR FITTINGS.
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