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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
Generic NameDressing, wound and burn, interactive
ApplicantOrganogenesis, Inc.
150 Dan Rd.
Canton, MA 02021
PMA NumberP950032
Supplement NumberS070
Date Received12/13/2012
Decision Date03/10/2014
Conversion Date08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement Type135 Review Track For 30-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  
APPROVAL OF AN ALTERNATE SOURCE OF A CRITICAL MATERIAL USED IN THE MANUFACTURE OF APLIGRAF.
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