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U.S. Department of Health and Human Services

Devices@FDA
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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 (GRAFTSKIN)
Generic NameDressing, wound and burn, interactive
ApplicantOrganogenesis, Inc.
150 Dan Rd.
Canton, MA 02021
PMA NumberP950032
Supplement NumberS026
Date Received08/15/2001
Decision Date09/14/2001
Conversion Date08/14/2013
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
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
MODIFICATION TO THE SHIPPER BOX TO NOW CONTAIN 12 POUNDS OF EUTECTIC BRICKS TO MAINTAIN TEMPERATURES ABOVE 20 DEGREES CELCIUS FOR THE 72 HOUR DURATION.
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