- Device
- MitraClip™ G5 Delivery System (CDS0801-NT, CDS0801-NTW, CDS0801-XT, CDS0801-XTW)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S082
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2026-02-25
- Decision code
- APPR
- Date received
- 2025-11-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor design changes to the clip locking mechanism in the implant and to the delivery system handle of the MitraClip G5 and TriClip G5 Delivery Systems.