APLIGRAF (GRAFTSKIN)
FDA premarket approval P950032/S002 · decided 1999-01-06
Approval details
- PMA number
- P950032
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- APLIGRAF (GRAFTSKIN)
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Organogenesis, Inc.
- Date received
- 1998-06-30
- Decision date
- 1999-01-06
- Days to decision
- 190 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Canton, MA
- Statement
- Response to conditions of approval cited in May 22, 1998, Approval Order: 1)revisions in karyology, growth rate and morphology testing and 2)Protocol 98-VSU-002, "A Prospective Study to Determine the Longevity of Apligraf Cells on Patients with Venous Ulcers" as well as the cited methods for obtaining documentation on the viral inactivation processes for transferrin.
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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 |