- Device
- MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System, and MitraClip G4 Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S037
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2020-02-26
- Decision code
- OK30
- Date received
- 2020-01-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the bonding process of the radiopaque ring and Delivery Catheter shaft of the MitraClip NTR/XTR and G4 Clip Delivery Systems.