ARISTA AH, ARISTA AH FLEXITIP/FLEXITIP XL/FLEXITIP XL-R
FDA premarket approval P050038/S026 · decided 2015-09-09
Approval details
- PMA number
- P050038
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARISTA AH, ARISTA AH FLEXITIP/FLEXITIP XL/FLEXITIP XL-R
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- Davol, Inc.
- Date received
- 2015-08-10
- Decision date
- 2015-09-09
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Warwick, RI
- Statement
- CHANGES IN THE MANUFACTURING PROCESS OF THE ARISTA AH FLEXITIP XL-R STAINLESS STEEL COMPONENT.
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| 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 |