| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | APLIGRAF (GRAFTSKIN) |
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| Classification Name | dressing, wound and burn, interactive |
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| Generic Name | graftskin |
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| Applicant | ORGANOGENESIS, INC. |
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| PMA Number | P950032 |
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| Supplement Number | S016 |
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| Date Received | 12/23/1999 |
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| Decision Date | 06/20/2000 |
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| Product Code | |
| Docket Number | 00M-1508 |
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| Notice Date | 09/11/2000 |
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| Advisory Committee |
General & Plastic Surgery |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | labeling change - indications |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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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 Order |
Approval Order
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