PMA P100009S078

Device: MitraClip G5 Delivery System
Applicant: ABBOTT MEDICAL
PMA number: P100009
Supplement: S078
Product code: NKM
Decision date: 2025-08-20
Classification: Cardiovascular
Generic name: Mitral valve repair devices
Approval order statement: Approval for updates to the Instructions for Use (IFU) to clarify information on several preparation steps for the MitraClip G5 and TriClip G5 Delivery Systems devices due to the design differences with the MitraClip G4 and TriClip G4 Delivery Systems.

Current openFDA PMA Record#

Device: MitraClip G5 Delivery System
Applicant: ABBOTT MEDICAL
PMA number: P100009
Supplement: S078
Product code: NKM
Generic name: Mitral valve repair devices
Decision date: 2025-08-20
Decision code: APPR
Date received: 2025-07-21
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for updates to the Instructions for Use (IFU) to clarify information on several preparation steps for the MitraClip G5 and TriClip G5 Delivery Systems devices due to the design differences with the MitraClip G4 and TriClip G4 Delivery Systems.