APILGRAF(GRAFTSKIN)
FDA premarket approval P950032/S028 · decided 2002-01-17
Approval details
- PMA number
- P950032
- Supplement
- S028
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- APILGRAF(GRAFTSKIN)
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Organogenesis, Inc.
- Date received
- 2001-10-24
- Decision date
- 2002-01-17
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Canton, MA
- Statement
- APPROVAL FOR REMOVAL OF THE CMV IGG ANTIBODY TEST FROM THE ANTEPARTUM MATERNAL DONOR SERUM TESTING PANEL, WHILE CONTINUING TO TEST THE MATERNAL DONOR SERA FOR CMV IGM ANTIBODIES AND THE MASTER CELL BANK FOR CMV VIA PCR.
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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 |