- Device
- MitraClip™ G4 Clip Delivery System, MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S049
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2022-11-20
- Decision code
- OK30
- Date received
- 2022-11-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the flexural rigidity acceptance criteria for the MitraClip delivery catheter shaft component.