TriClip G4 System
FDA premarket approval P230007 · decided 2024-04-01
Approval details
- PMA number
- P230007
- Trade name
- TriClip G4 System
- Generic name
- Tricuspid valve repair device, percutaneously delivered
- Applicant
- ABBOTT MEDICAL
- Date received
- 2023-03-02
- Decision date
- 2024-04-01
- Days to decision
- 396 days
- Decision code
- APPR
- Product code
- NPS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for the TriClip G4 System. This device is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are at intermediate or greater risk for surgery and in whom transcatheter edge-to-edge valve repair is clinically appropriate and is expected to reduce tricuspid regurgitation severity to moderate or less, as determined by a multidisciplinary heart team.
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