PMA P870076S023
- Device
- Falope-Ring Band Contraceptive Tubal Occlusion System
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P870076
- Supplement
- S023
- Product code
- KNH
- Decision date
- 2016-09-23
- Classification
- Laparoscopic Contraceptive Tubal Occlusion Device
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Approval order statement
- Approval for a change in the material used to thermoform the tray and tray insert from Verex 5400, to Polyethylene Terephthalate Glycol (PETG).
Current openFDA PMA Record#
- Device
- Falope-Ring Band Contraceptive Tubal Occlusion System
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P870076
- Supplement
- S023
- Product code
- KNH
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Decision date
- 2016-09-23
- Decision code
- APPR
- Date received
- 2016-07-18
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change in the material used to thermoform the tray and tray insert from Verex 5400, to Polyethylene Terephthalate Glycol (PETG).