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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 NumberS016
Date Received08/05/2013
Decision Date10/24/2013
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 for use of covidien¿s petrolatum gauze as sterilized via gamma irradiation instead of the former autoclave, steam heat sterilization method. The manufacturing change now includes a 4 hour dry heat step to facilitate wicking of the petrolatum in to the gauze which was formerly accomplished by the steam heat conditions.
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