APLIGRAF(R)(GRAFTSKIN)
FDA premarket approval P950032/S019 · decided 2001-11-19
Approval details
- PMA number
- P950032
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- APLIGRAF(R)(GRAFTSKIN)
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Organogenesis, Inc.
- Date received
- 2000-11-03
- Decision date
- 2001-11-19
- Days to decision
- 381 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Canton, MA
- 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 TRE
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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 |