Filshie Clip (Mark VI) System
FDA premarket approval P920046/S014 · decided 2024-09-16
Approval details
- PMA number
- P920046
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Filshie Clip (Mark VI) System
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Applicant
- Femcare , Ltd.
- Date received
- 2023-10-03
- Decision date
- 2024-09-16
- Days to decision
- 349 days
- Decision code
- APPR
- Product code
- KNH
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Romsey
- Statement
- approval to change the primary packaging of the Filshie Clip, change the sterilization process, and change the stated shelf life
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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 |