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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 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 NumberS072
Date Received04/24/2013
Decision Date07/11/2013
Conversion Date 08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE INTRODUCTION OF HUMAN EPIDERMAL KERATINOCYTE CELLSTRAIN 197 (HEP 197) FOR USE IN THE MANUFACTURE OF APLIGRAF, AND FOR APPROVAL OF A CHANGE FROM THE CURRENT TEST ASSAY FOR DETECTION OF CERTAIN VIRAL CONTAMINANTS TO A REAL-TIME PCR METHOD FROM A CONVENTIONAL GEL-BASED PCR METHOD.
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