- Device
- TriClip™ G4 Clip Delivery System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230007
- Supplement
- S001
- Product code
- NPS
- Generic name
- Tricuspid valve repair device, percutaneously delivered
- Decision date
- 2024-05-09
- Decision code
- OK30
- Date received
- 2024-04-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a manufacturing location change of a component supplier, a change to the electropolishing process of the CDS Clip Arm components from a manual to an automated process, and use of an additional sterilization line, aeration room, and pre-existing preconditioning room to increase sterilization capacity at the currently approved contract sterilization facility