- Device
- MitraClip™ G4 Clip Delivery System; MitraClip™ NTR Clip Delivery System; MitraClip™ XTR Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S075
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2025-06-25
- Decision code
- OK30
- Date received
- 2025-05-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of an alternative measurement system for evaluating the distance between two components of the Sleeve Toggle Subassembly