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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 NumberS001
Date Received06/17/1998
Decision Date07/09/1998
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  
The 30-day Notice requested a manufacturing process change fro Apligraf(TM). The requested change will replace 8 laboratory-scale incubators currently used in the Apligraf(TM) manufacturing process, FORMA Steri-Cult 200, model #3033, with 6 production-scale incubators manufactured by Lunaire Corporation (model # CI0641W-6SPL). The change will require a lower temperature setpoint in the Lunaire incubators during manufacturing.
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