TriClip G4 System

FDA premarket approval P230007 · Tricuspid valve repair device, percutaneously delivered

PMA numberP230007

Approval

Applicant
Abbott Medical
Received
March 2, 2023
Decision date
April 1, 2024 (APPR)
Supplements
22, latest June 25, 2026
Product code
NPS – Tricuspid Valve Repair Device, Percutaneously Delivered

Official FDA PMA record

Approval order 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.