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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(R)(GRAFTSKIN)
Generic NameDressing, wound and burn, interactive
ApplicantORGANOGENESIS, INC.
150 DAN RD.
CANTON, MA 02021
PMA NumberP950032
Supplement NumberS021
Date Received11/21/2000
Decision Date12/21/2000
Conversion Date 08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE RELATIVE HUMIDITY OF THE LUNAIRE INCUBATORS USED IN THE APLIGRAF MANUFACTURING PROCESS. THE CHANGE WILL DECREASE THE RISK OF BACTERIAL CONTAMINATION DUE TO WATERBORNE ORGANISMS DURING THE MANUFACTURING PROCESS.
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