- Device
- TriClip™ G4 Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230007
- Supplement
- S006
- Product code
- NPS
- Generic name
- Tricuspid valve repair device, percutaneously delivered
- Decision date
- 2024-10-22
- Decision code
- OK30
- Date received
- 2024-09-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in the incoming inspection requirement for a delivery system component, and modification of specific dimensional and visual inspection requirements for the Gripper Line