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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceORCEL BILAYERED CELLULAR MATRIX
Generic NameDressing, wound and burn, interactive
ApplicantForticell Bioscience
3960 Broadway,
New York, NY 10032
PMA NumberP010016
Supplement NumberS001
Date Received10/18/2001
Decision Date12/06/2001
Conversion Date08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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