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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 NumberS001
Date Received04/08/2008
Decision Date08/12/2008
Product Code
OCE[ Registered Establishments with OCE ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 75 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a change in primary supplier of hydrocortisone powder usp, used in the manufacturing of epice18 cultured epidermal autografts. The device, as modified, will be marketed under the trade name epicels and is indicated for use in patients who have deep dermal or fuill thickness bums comprising a total body surface area ofgreater than or equal to 30%.
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