PMA P230007S005

Device: TriClip G5 Delivery System
Applicant: ABBOTT MEDICAL
PMA number: P230007
Supplement: S005
Product code: NPS
Decision date: 2024-12-31
Classification: Cardiovascular
Generic name: Tricuspid valve repair device, percutaneously delivered
Approval order statement: Approval for the MitraClip G5 Delivery System and the TriClip G5 Delivery System, which include modifications to the Delivery System Handles and simplification of the IFU procedural steps to improve the ergonomics of the Clip Delivery System to enhance physician usability, as well as minor labeling, packaging, specification, and manufacturing process changes. Two of the changes, a minor specification change and an alternate Female Luer component, will also apply to the MitraClip G4 Delivery System and TriClip G4 Delivery System.

Current openFDA PMA Record#

Device: TriClip G5 Delivery System
Applicant: ABBOTT MEDICAL
PMA number: P230007
Supplement: S005
Product code: NPS
Generic name: Tricuspid valve repair device, percutaneously delivered
Decision date: 2024-12-31
Decision code: APPR
Date received: 2024-07-03
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the MitraClip G5 Delivery System and the TriClip G5 Delivery System, which include modifications to the Delivery System Handles and simplification of the IFU procedural steps to improve the ergonomics of the Clip Delivery System to enhance physician usability, as well as minor labeling, packaging, specification, and manufacturing process changes. Two of the changes, a minor specification change and an alternate Female Luer component, will also apply to the MitraClip G4 Delivery System and TriClip G4 Delivery System.