PMA P230007S018

Device: TriClip G4 System
Applicant: ABBOTT MEDICAL
PMA number: P230007
Supplement: S018
Product code: NPS
Decision date: 2025-10-17
Classification: Cardiovascular
Generic name: Tricuspid valve repair device, percutaneously delivered
Approval order statement: the substitution of commercially available DC shaft components used for process monitoring with vendor inspected DC shaft components with specific reject reasons that do not impact bond integrity, and a change in the incoming sampling plan of 8 components from 100% inspection to RQL

Current openFDA PMA Record#

Device: TriClip G4 System
Applicant: ABBOTT MEDICAL
PMA number: P230007
Supplement: S018
Product code: NPS
Generic name: Tricuspid valve repair device, percutaneously delivered
Decision date: 2025-10-17
Decision code: OK30
Date received: 2025-09-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the substitution of commercially available DC shaft components used for process monitoring with vendor inspected DC shaft components with specific reject reasons that do not impact bond integrity, and a change in the incoming sampling plan of 8 components from 100% inspection to RQL