- Device
- Filshie Clip (Mark VI) System
- Applicant
- Femcare , Ltd.
- PMA number
- P920046
- Supplement
- S012
- Product code
- KNH
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Decision date
- 2022-01-06
- Decision code
- APPR
- Date received
- 2021-12-08
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for revisions to the Instructions for Use to clarify symptomatic versus asymptomatic clip migration rates for the Filshie Clip (Mark VI) System.