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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 (GRAFTSKIN)
Generic NameDressing, wound and burn, interactive
ApplicantORGANOGENESIS, INC.
150 DAN RD.
CANTON, MA 02021
PMA NumberP950032
Supplement NumberS016
Date Received12/23/1999
Decision Date06/20/2000
Conversion Date 08/14/2013
Product Code MGR 
Docket Number 00M-1508
Notice Date 09/11/2000
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR USE WITH STANDARD DIABETIC FOOT ULCER CARE FOR THE TREATMENT OF FULL-THICKNESS NEUROPATHIC DIABETIC FOOT ULCERS OF GREATER THAN THREE WEEKS DURATION WHICH HAVE NOT ADEQUATELY RESPONDED TO CONVENTIONAL ULCER THERAPY AND WHICH EXTEND THROUGH THE DERMIS BUT WITHOUT TENDON, MUSCLE, CAPSULE OR BONE EXPOSURE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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