|
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 |
|
HDE Number | H990002 |
Supplement Number | S014 |
Date Received | 10/18/2012 |
Decision Date | 02/04/2016 |
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 assessment of residual 3t3 murine cell in epicel and plan for reporting this information to end users. |