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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
Classification Namedressing, wound and burn, interactive
Generic Namedressing, wound and burn, interactive
Applicant
ORGANOGENESIS, INC.
150 dan rd.
canton, MA 02021
PMA NumberP950032
Supplement NumberS064
Date Received08/05/2011
Decision Date09/22/2011
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR THE INTRODUCTION OF HUMAN DERMAL FIBROBLAST CELL STRAIN (HDF 072) INTO THE MANUFACTURE OF APLIGRAF.
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