- Device
- MitraClip™ G4 Clip Delivery System; MitraClip™ G5 Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S080
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2025-09-30
- Decision code
- OK30
- Date received
- 2025-09-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- additional alternate component suppliers and alternate sub-suppliers of raw materials for components used in the manufacturing process for the MitraClip Delivery Systems and the TriClip Delivery Systems