APLIGRAF (GRAFTSKIN)
FDA premarket approval P950032/S016 · decided 2000-06-20
Approval details
- PMA number
- P950032
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- APLIGRAF (GRAFTSKIN)
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Organogenesis, Inc.
- Date received
- 1999-12-23
- Decision date
- 2000-06-20
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Canton, MA
- 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.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| FortiShield (Biosynthetic Wound Matrix) (K212579) | Organogenesis, Inc. | 2023-05-02 |
| PuraPly Micronized Wound Matrix (PuraPly MZ) (K220317) | Organogenesis, Inc. | 2022-07-01 |
| FORTAGEN ORAL MEMBRANE (K071555) | Organogenesis, Inc. | 2007-08-30 |
| FORTADERM ANTIMICROBIAL WOUND DRESSING (K051647) | Organogenesis, Inc. | 2005-11-08 |
| CUFFPATCH (K042809) | Organogenesis, Inc. | 2004-11-02 |
| FORTAFLEX SURGICAL SLING (K021107) | Organogenesis, Inc. | 2002-05-15 |
| FORTAFLEX SURGICAL MESH (K021105) | Organogenesis, Inc. | 2002-05-10 |
| FORTAFLEX SURGICAL MESH (K020049) | Organogenesis, Inc. | 2002-03-18 |