Arista AH
FDA premarket approval P050038/S040 · decided 2023-08-09
Approval details
- PMA number
- P050038
- Supplement
- S040
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Arista AH
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- Davol, Inc.
- Date received
- 2022-04-12
- Decision date
- 2023-08-09
- Days to decision
- 484 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Warwick, RI
- Statement
- Approval for the use of an alternate emulsifier used in the manufacturing of DSM-A (the non-sterile powder component of Arista AH).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Bard® Mesh; Bard® Mesh Pre-Shaped (K251557) | Davol, Inc. | 2025-06-12 |
| Bard Soft Mesh; Bard Soft Mesh Pre-Shaped (K250098) | Davol, Inc. | 2025-04-09 |
| AQUASENS FLUID MONITORING SYSTEM (K031213) | Davol, Inc. | 2003-04-30 |
| DAVOL ARTHROVENT OUTFLOW TUBING (K030307) | Davol, Inc. | 2003-02-13 |
| COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 (K003323) | Davol, Inc. | 2001-01-22 |
| DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005 (K003790) | Davol, Inc. | 2000-12-22 |
| DAVOL ATS (K931899) | Davol, Inc. | 1994-11-15 |
| DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE (K941334) | Davol, Inc. | 1994-06-14 |