PMA P870076
- Device
- Falope Ring Band and Applicator Systems
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P870076
- Supplement
- S027
- Product code
- KNH
- Decision date
- 2021-05-19
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Approval order statement
- Update to sterilization parameters for the reduction of gas concentration in the ethylene oxide (EO) sterilization process.
Current openFDA PMA Record#
- Device
- Falope Ring Band and Applicator Systems
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P870076
- Supplement
- S027
- Product code
- KNH
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Decision date
- 2021-05-19
- Decision code
- OK30
- Date received
- 2021-04-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to sterilization parameters for the reduction of gas concentration in the ethylene oxide (EO) sterilization process.