PMA P100009S067

Device: MitraClip G5 System
Applicant: ABBOTT MEDICAL
PMA number: P100009
Supplement: S067
Product code: NKM
Decision date: 2024-12-31
Classification: Cardiovascular
Generic name: Mitral valve repair devices
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: MitraClip G5 System
Applicant: ABBOTT MEDICAL
PMA number: P100009
Supplement: S067
Product code: NKM
Generic name: Mitral valve repair devices
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.