PMA P230007S019

Device: TriClip™ G5 Delivery System (TCDS0801-NT, TCDS0801-NTW, TCDS0801-XT, TCDS0801-XTW)
Applicant: ABBOTT MEDICAL
PMA number: P230007
Supplement: S019
Product code: NPS
Decision date: 2026-02-25
Classification: Cardiovascular
Generic name: Tricuspid valve repair device, percutaneously delivered
Approval order statement: Approval for minor design changes to the clip locking mechanism in the implant and to the delivery system handle of the MitraClip G5 and TriClip G5 Delivery Systems.

Current openFDA PMA Record#

Device: TriClip™ G5 Delivery System (TCDS0801-NT, TCDS0801-NTW, TCDS0801-XT, TCDS0801-XTW)
Applicant: ABBOTT MEDICAL
PMA number: P230007
Supplement: S019
Product code: NPS
Generic name: Tricuspid valve repair device, percutaneously delivered
Decision date: 2026-02-25
Decision code: APPR
Date received: 2025-11-26
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for minor design changes to the clip locking mechanism in the implant and to the delivery system handle of the MitraClip G5 and TriClip G5 Delivery Systems.