PMA P870076S021
- Device
- DISPOSABLE FALOPE-RING BAND APPLICATOR KITS
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P870076
- Supplement
- S021
- Product code
- KNH
- Decision date
- 2016-03-02
- Classification
- Laparoscopic Contraceptive Tubal Occlusion Device
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Approval order statement
- Change in supplier from Senior Operations LLC (formerly known as GA MFG Precision) to XL Precision for the manufacture of the Trocar Knife (Part No. 004556-503) and a manufacturing process change to produce a one-piece configuration Trocar Knife.
Current openFDA PMA Record#
- Device
- DISPOSABLE FALOPE-RING BAND APPLICATOR KITS
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P870076
- Supplement
- S021
- Product code
- KNH
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Decision date
- 2016-03-02
- Decision code
- OK30
- Date received
- 2016-02-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in supplier from Senior Operations LLC (formerly known as GA MFG Precision) to XL Precision for the manufacture of the Trocar Knife (Part No. 004556-503) and a manufacturing process change to produce a one-piece configuration Trocar Knife.