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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.
 
DeviceAPLIGRAF (GRAFTSKIN)
Generic NameDressing, wound and burn, interactive
ApplicantORGANOGENESIS, INC.
150 DAN RD.
CANTON, MA 02021
PMA NumberP950032
Supplement NumberS020
Date Received11/09/2000
Decision Date11/07/2001
Conversion Date 08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE FINAL PRODUCT SHIPPING MEDIUM INCLUDING THE REPLACEMENT OF BOVINE INSULIN WITH FULL CHAIN HUMAN RECOMBINANT INSULIN AND THE ELIMINATION OF BSA, TRANSFERRIN, AND TRIIODOTHYRONINE.
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