Filshie Clip (Mark VI) System
FDA premarket approval P920046/S012 · decided 2022-01-06
Approval details
- PMA number
- P920046
- Supplement
- S012
- Supplement type
- Special (Immediate Track)
- 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
- 2021-12-08
- Decision date
- 2022-01-06
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- KNH
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Romsey
- Statement
- Approval for revisions to the Instructions for Use to clarify symptomatic versus asymptomatic clip migration rates for the Filshie Clip (Mark VI) System.
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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 |