- Device
- TriClip Systems
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230007
- Supplement
- S023
- Product code
- NPS
- Generic name
- Tricuspid valve repair device, percutaneously delivered
- 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