Filshie Clip (Mark VI) System
FDA premarket approval P920046/S015 · decided 2024-12-03
Approval details
- PMA number
- P920046
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Filshie Clip (Mark VI) System
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Applicant
- Femcare , Ltd.
- Date received
- 2024-09-05
- Decision date
- 2024-12-03
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- KNH
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Romsey
- Statement
- Approval for revising the Instructions for Use (IFU) for the Filshie Clip to harmonize IFU labeling internationally.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LI VASECTOMY (K932465) | Femcare , Ltd. | 1994-03-02 |
| ADD-A-CATH (K884061) | Femcare , Ltd. | 1988-10-25 |