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 | APILGRAF(GRAFTSKIN) |
Generic Name | Dressing, wound and burn, interactive |
Applicant | ORGANOGENESIS, INC. 150 DAN RD. CANTON, MA 02021 |
PMA Number | P950032 |
Supplement Number | S028 |
Date Received | 10/24/2001 |
Decision Date | 01/17/2002 |
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 | Other |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REMOVAL OF THE CMV IGG ANTIBODY TEST FROM THE ANTEPARTUM MATERNAL DONOR SERUM TESTING PANEL, WHILE CONTINUING TO TEST THE MATERNAL DONOR SERA FOR CMV IGM ANTIBODIES AND THE MASTER CELL BANK FOR CMV VIA PCR. |
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