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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 NumberS012
Date Received07/29/2011
Decision Date04/17/2012
Product Code
OCE[ Registered Establishments with OCE ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Approval to change the current epicel graft tray foil lid, as obtained from oliver-tolas healthcare packaging (tpc-0814), to the new foil lid, tpc-0777, aspurchased from the same manufacturer.
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