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 | ORCEL BILAYERED CELLULAR MATRIX |
Generic Name | Dressing, wound and burn, interactive |
Applicant | FORTICELL BIOSCIENCE 3960 BROADWAY NEW YORK, NY 10032 |
PMA Number | P010016 |
Supplement Number | S002 |
Date Received | 12/27/2001 |
Decision Date | 01/17/2002 |
Conversion Date
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08/14/2013 |
Product Code |
MGR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR USE OF CELL LINE FS-183 IN THE COMMERCIAL MANUFACTURE OF ORCEL BILAYERED CELLULAR MATRIX. |
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