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Trade Name | EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) |
Classification Name | cultured epithelial autograft |
Generic Name | cultured epithelial autograft |
Applicant |
GENZYME CORP. |
200 crossing blvd |
framingham, MA 01702 |
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HDE Number | H990002 |
Supplement Number | S012 |
Date Received | 07/29/2011 |
Decision Date | 04/17/2012 |
Product Code | |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval to change the current epicel graft tray foil lid, as obtained from oliver-tolas healthcare packaging (tpc-0814), to the new foil lid, tpc-0777, aspurchased from the same manufacturer. |