PMA P870076S017
- Device
- FALOPE-RING BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P870076
- Supplement
- S017
- Product code
- KNH
- Decision date
- 2016-07-20
- Classification
- Laparoscopic Contraceptive Tubal Occlusion Device
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Approval order statement
- Approval to recover and repackage intact and unused Disposable Falope-Ring® Band Applicators, subject them to a second sterilization process, and make them available for sale and distribution.
Current openFDA PMA Record#
- Device
- FALOPE-RING BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P870076
- Supplement
- S017
- Product code
- KNH
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Decision date
- 2016-07-20
- Decision code
- APPR
- Date received
- 2015-11-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to recover and repackage intact and unused Disposable Falope-Ring® Band Applicators, subject them to a second sterilization process, and make them available for sale and distribution.