|
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 | S013 |
Date Received | 10/19/2011 |
Decision Date | 02/04/2016 |
Product Code | |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for labeling changes to include additional safety information and reported squamous cell carcinoma events. |