PMA P920046S014
- Device
- Filshie Clip (Mark VI) System
- Applicant
- Femcare , Ltd.
- PMA number
- P920046
- Supplement
- S014
- Product code
- KNH
- Decision date
- 2024-09-16
- Classification
- Obstetrics/Gynecology
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Approval order statement
- approval to change the primary packaging of the Filshie Clip, change the sterilization process, and change the stated shelf life
Current openFDA PMA Record#
- Device
- Filshie Clip (Mark VI) System
- Applicant
- Femcare , Ltd.
- PMA number
- P920046
- Supplement
- S014
- Product code
- KNH
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Decision date
- 2024-09-16
- Decision code
- APPR
- Date received
- 2023-10-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to change the primary packaging of the Filshie Clip, change the sterilization process, and change the stated shelf life