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  1. Recently-Approved Devices

TriClip G4 System – P230007

 

The clip implant has arms that open and close, allowing them to attach to the flaps of the tricuspid valve

 


This is a brief overview of information related to the FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for the FDA’s approval.

Product Name: TriClip G4 System
PMA Applicant: Abbott Medical
Address: 177 Country Road B East, Saint Paul, MN 55117
Approval Date: April 01, 2024
Approval Letter: Approval Order

What is it?

The TriClip G4 System is used to treat tricuspid regurgitation (leaky tricuspid valve) often caused by an enlarged heart or damaged tricuspid valve leaflets, without open-heart surgery. The TriClip includes a clip placed into the body, a delivery catheter, and accessories. The clip implant has arms that open and close, allowing them to attach to the flaps of the tricuspid valve of the heart (leaflets).

 
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