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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.
Classification Namecultured epithelial autograft
Generic Namecultured epithelial autograft
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
Supplement Typehde original
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Approval for the epicel® (cultured epidermal autografts). This device is indicated for use in patients who have deep dermal or full thickness burns comprising a total body surface area of greater than or equal to 30%. It may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
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