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. |
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Device | APLIGRAF (GRAFTSKIN) |
Generic Name | Dressing, wound and burn, interactive |
Applicant | ORGANOGENESIS, INC. 150 DAN RD. CANTON, MA 02021 |
PMA Number | P950032 |
Supplement Number | S020 |
Date Received | 11/09/2000 |
Decision Date | 11/07/2001 |
Conversion Date
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08/14/2013 |
Product Code |
MGR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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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