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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received02/05/1999
Decision Date10/25/2007
Product Code
OCE[ Registered Establishments with OCE ]
Docket Number 07M-0415
Notice Date 11/07/2007
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductYes
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Labeling Part 2
Supplements: S001 S002 S003 S005 S006 S008 S009 S010 S011 
S012 S013 S014 S015 S016 
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