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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 NumberS002
Date Received12/27/2001
Decision Date01/17/2002
Conversion Date08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR USE OF CELL LINE FS-183 IN THE COMMERCIAL MANUFACTURE OF ORCEL BILAYERED CELLULAR MATRIX.
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