PMA P870076S020
- Device
- DISPOSABLE FALOPE-RING BANK APPLICATOR KITS
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P870076
- Supplement
- S020
- Product code
- KNH
- Decision date
- 2016-02-09
- Classification
- Laparoscopic Contraceptive Tubal Occlusion Device
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Approval order statement
- Change in suppliers from Senior Operations LLC (formerly known as GA MFG Precision) to C&M Machine for the manufacture of the following components of the subject device: 1) Locating Pin (part number 005267); and 2) Vercap Insert Seal Base (part number 005137).
Current openFDA PMA Record#
- Device
- DISPOSABLE FALOPE-RING BANK APPLICATOR KITS
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P870076
- Supplement
- S020
- Product code
- KNH
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Decision date
- 2016-02-09
- Decision code
- OK30
- Date received
- 2016-01-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in suppliers from Senior Operations LLC (formerly known as GA MFG Precision) to C&M Machine for the manufacture of the following components of the subject device: 1) Locating Pin (part number 005267); and 2) Vercap Insert Seal Base (part number 005137).