- Device
- MitraClip NT Clip Delivery System, MitraClip XT Clip Delivery System, and MitraClip G4 Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S039
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2021-03-09
- Decision code
- OK30
- Date received
- 2021-02-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Semi-automation of the mandrel removal manufacturing step for the Delivery Catheter shaft.