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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
Classification Namedressing, wound and burn, interactive
Generic Namegraftskin
ApplicantORGANOGENESIS, INC.
PMA NumberP950032
Supplement NumberS029
Date Received02/04/2002
Decision Date03/14/2002
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of a new cell strain for the production of apligraf (i. E. , hep990), and the replacement of flow cytometric allogenicity and immuno-phenotyping assays used in cell strain characterization with a similar cell purity assay.
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