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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.
 
DeviceAPLIGRAF
Generic NameDressing, wound and burn, interactive
ApplicantORGANOGENESIS, INC.
150 DAN RD.
CANTON, MA 02021
PMA NumberP950032
Supplement NumberS046
Date Received03/10/2008
Decision Date03/19/2008
Conversion Date 08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE INTRODUCTION OF ADDITIONAL IN-PROCESS BIOBURDEN TESTING AND QUALITY ASSURANCE STEPS TO ENHANCE THE SAFETY PROFILE OF APLIGRAF.
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