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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 NumberS002
Date Received06/30/1998
Decision Date01/06/1999
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Response to conditions of approval cited in may 22, 1998, approval order: 1)revisions in karyology, growth rate and morphology testing and 2)protocol 98-vsu-002, "a prospective study to determine the longevity of apligraf cells on patients with venous ulcers" as well as the cited methods for obtaining documentation on the viral inactivation processes for transferrin.
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