PMA P920046
- Device
- Filshie Clip (Mark VI) System
- Applicant
- Femcare , Ltd.
- PMA number
- P920046
- Supplement
- S012
- Product code
- KNH
- Decision date
- 2024-12-03
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Approval order statement
- Approval for revising the Instructions for Use (IFU) for the Filshie Clip to harmonize IFU labeling internationally.
Current openFDA PMA Record#
- Device
- Filshie Clip (Mark VI) System
- Applicant
- Femcare , Ltd.
- PMA number
- P920046
- Supplement
- S015
- Product code
- KNH
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Decision date
- 2024-12-03
- Decision code
- APPR
- Date received
- 2024-09-05
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for revising the Instructions for Use (IFU) for the Filshie Clip to harmonize IFU labeling internationally.