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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameEPICEL (CULTURED EPIDERMAL AUTOGRAFTS)
Classification Namecultured epithelial autograft
Generic Namecultured epithelial autograft
Applicant
Genzyme Corp.
200 crossing blvd.
framingham, MA 01702
HDE NumberH990002
Supplement NumberS013
Date Received10/19/2011
Decision Date02/04/2016
Product Code
OCE[ Registered Establishments with OCE ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Approval for labeling changes to include additional safety information and reported squamous cell carcinoma events.
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