TriClip G4 System
FDA premarket approval P230007/S010 · decided 2025-05-09
Approval details
- PMA number
- P230007
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TriClip G4 System
- Generic name
- Tricuspid valve repair device, percutaneously delivered
- Applicant
- ABBOTT MEDICAL
- Date received
- 2025-02-14
- Decision date
- 2025-05-09
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- NPS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for minor design, material, and manufacturing changes to the Lock Knob Shaft component of the delivery system.
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