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U.S. Department of Health and Human Services

Devices@FDA
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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 NumberS002
Date Received06/30/1998
Decision Date01/06/1999
Conversion Date08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
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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