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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
Generic NameDressing, wound and burn, interactive
ApplicantOrganogenesis, Inc.
150 Dan Rd.
Canton, MA 02021
PMA NumberP950032
Supplement NumberS029
Date Received02/04/2002
Decision Date03/14/2002
Conversion Date08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
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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