PMA P870076S012
- Device
- DISPOSABLE FALOPE-RING BAND APPLICATOR KITS
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P870076
- Supplement
- S012
- Product code
- KNH
- Decision date
- 2012-07-05
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Approval order statement
- CHANGE IN THE QUALITY CONTROL METHOD USED DURING THE TRAY AND POUCH MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- DISPOSABLE FALOPE-RING BAND APPLICATOR KITS
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P870076
- Supplement
- S012
- Product code
- KNH
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Decision date
- 2012-07-05
- Decision code
- OK30
- Date received
- 2012-06-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE QUALITY CONTROL METHOD USED DURING THE TRAY AND POUCH MANUFACTURING PROCESS.