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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 PMA to get an up-to-date view of this device.
 
Trade NameORCEL BILAYERED CELLULAR MATRIX
Classification Namedressing, wound and burn, interactive
Generic Nameinteractive wound and burn dressing
ApplicantORTEC INTL., INC.
PMA NumberP010016
Supplement NumberS002
Date Received12/27/2001
Decision Date01/17/2002
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of cell line fs-183 in the commercial manufacture of orcel bilayered cellular matrix.
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