APLIGRAF(R)(GRAFTSKIN)
FDA premarket approval P950032/S021 · decided 2000-12-21
Approval details
- PMA number
- P950032
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- APLIGRAF(R)(GRAFTSKIN)
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Organogenesis, Inc.
- Date received
- 2000-11-21
- Decision date
- 2000-12-21
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Canton, MA
- Statement
- CHANGE IN THE RELATIVE HUMIDITY OF THE LUNAIRE INCUBATORS USED IN THE APLIGRAF MANUFACTURING PROCESS. THE CHANGE WILL DECREASE THE RISK OF BACTERIAL CONTAMINATION DUE TO WATERBORNE ORGANISMS DURING THE MANUFACTURING PROCESS.
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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 |