PMA P100009S046
- Device
- MitraClip G4 Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S046
- Product code
- NKM
- Decision date
- 2022-08-16
- Generic name
- Mitral valve repair devices
- Approval order statement
- Implement a revised sampling plan for torque strength testing of the Press-Fit Assembly of the MitraClip G4 Clip Delivery System 01410.
Current openFDA PMA Record#
- Device
- MitraClip G4 Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S046
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2022-08-16
- Decision code
- OK30
- Date received
- 2022-07-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement a revised sampling plan for torque strength testing of the Press-Fit Assembly of the MitraClip G4 Clip Delivery System 01410.