- Device
- TriClip G4 System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230007
- Supplement
- S020
- Product code
- NPS
- Generic name
- Tricuspid valve repair device, percutaneously delivered
- Decision date
- 2026-03-06
- Decision code
- OK30
- Date received
- 2026-02-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- harmonization across preconditioning parameters in preconditioning cells at one sterilization facility, and implementation of sustainable reduced ethylene oxide sterilization cycles at two other sterilization facilities