PMA P230007S015

Device: TriClip G5 Delivery System
Applicant: ABBOTT MEDICAL
PMA number: P230007
Supplement: S015
Product code: NPS
Decision date: 2025-08-20
Classification: Cardiovascular
Generic name: Tricuspid valve repair device, percutaneously delivered
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: TriClip G5 Delivery System
Applicant: ABBOTT MEDICAL
PMA number: P230007
Supplement: S015
Product code: NPS
Generic name: Tricuspid valve repair device, percutaneously delivered
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.