- Device
- MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System, MitraClip™ G4 Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S051
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2023-01-31
- Decision code
- OK30
- Date received
- 2023-01-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the raw material sub-supplier for the Lock Line component of the MitraClip delivery system.