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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/GRAFTSKIN
Generic NameDressing, wound and burn, interactive
ApplicantOrganogenesis, Inc.
150 Dan Rd.
Canton, MA 02021
PMA NumberP950032
Supplement NumberS024
Date Received06/18/2001
Decision Date07/16/2001
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
Approval Order Statement  
CHANGE TO USE AN ADDITIONAL SHIPPING CONTAINER FOR THE APLIGRAF(TM) DEVICE THAT WOULD MAINTAIN PRODUCT INTEGRITY FOR A PERIOD OF 72 HOURS. THE CHANGE WILL ALLOW FOR GREATER FLEXIBILITY WITH DOMESTIC SHIPMENTS BY ENSURING PRODUCT INTEGRITY FOR A LONGER PERIOD, AND REDUUCE WASTE.
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