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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 | S016 |
Date Received | 08/05/2013 |
Decision Date | 10/24/2013 |
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 for use of covidien¿s petrolatum gauze as sterilized via gamma irradiation instead of the former autoclave, steam heat sterilization method. The manufacturing change now includes a 4 hour dry heat step to facilitate wicking of the petrolatum in to the gauze which was formerly accomplished by the steam heat conditions. |