TriClip G4 System
FDA premarket approval P230007/S018 · decided 2025-10-17
Approval details
- PMA number
- P230007
- Supplement
- S018
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TriClip G4 System
- Generic name
- Tricuspid valve repair device, percutaneously delivered
- Applicant
- ABBOTT MEDICAL
- Date received
- 2025-09-19
- Decision date
- 2025-10-17
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NPS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- the substitution of commercially available DC shaft components used for process monitoring with vendor inspected DC shaft components with specific reject reasons that do not impact bond integrity, and a change in the incoming sampling plan of 8 components from 100% inspection to RQL
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