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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 NumberS001
Date Received10/18/2001
Decision Date12/06/2001
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of cell lines fs-143 and fs-145 in the commercial manufacture of orcel bilayered cellular matrix.
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