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. |
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Device | APLIGRAF(R)(GRAFTSKIN) |
Generic Name | Dressing, wound and burn, interactive |
Applicant | ORGANOGENESIS, INC. 150 DAN RD. CANTON, MA 02021 |
PMA Number | P950032 |
Supplement Number | S019 |
Date Received | 11/03/2000 |
Decision Date | 11/19/2001 |
Conversion Date
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08/14/2013 |
Product Code |
MGR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH 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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