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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameAPLIGRAF (GRAFTSKIN)
Classification Namedressing, wound and burn, interactive
Generic Namegraftskin
ApplicantORGANOGENESIS, INC.
PMA NumberP950032
Supplement NumberS001
Date Received06/17/1998
Decision Date07/09/1998
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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