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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(R)(GRAFTSKIN)
Generic NameDressing, wound and burn, interactive
ApplicantORGANOGENESIS, INC.
150 DAN RD.
CANTON, MA 02021
PMA NumberP950032
Supplement NumberS019
Date Received11/03/2000
Decision Date11/19/2001
Conversion Date 08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR PATIENT BROCHURES FOR PATIENTS WITH CHRONIC VENOUS INSUFFICIENCY AND DIABETIC ULCERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME APLIGRAF AND IS INDICATED FOR USE WITH STANDARD THERAPEUTIC COMPRESSION FOR THE TREATMENT OF NON-INFECTED PARTIAL AND FULL-THICKNESS SKIN ULCERS DUE TO VENOUS INSUFFICIENCY OF GREATER THAN 1 MONTH DURATION AND WHICH HAVE NOT ADEQUATELY RESPONDED TO CONVENTIONAL ULCER THERAPY AND 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.
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