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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 NumberS004
Date Received10/28/1998
Decision Date01/06/1999
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason pas protocal supplement ode/oir
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 of the viral inactivation processes for transferrin.
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