PMA P100009S086
- Device
- MitraClip Systems
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S086
- Product code
- NKM
- Decision date
- 2026-06-25
- Classification
- Cardiovascular
- Generic name
- Mitral valve repair devices
- Approval order statement
- a new sub-tier supplier for the polyester fibers used to manufacture the suture component of the Clip implants of the MitraClip and TriClip Delivery Systems
Current openFDA PMA Record#
- Device
- MitraClip Systems
- Applicant
- ABBOTT MEDICAL
- PMA number
- P100009
- Supplement
- S086
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2026-06-25
- Decision code
- OK30
- Date received
- 2026-05-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new sub-tier supplier for the polyester fibers used to manufacture the suture component of the Clip implants of the MitraClip and TriClip Delivery Systems