PMA P100009S081

Device: MITRACLIP DELIVERY SYSTEM
Applicant: ABBOTT MEDICAL
PMA number: P100009
Supplement: S081
Product code: NKM
Decision date: 2025-10-17
Classification: Cardiovascular
Generic name: Mitral valve repair devices
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: MITRACLIP DELIVERY SYSTEM
Applicant: ABBOTT MEDICAL
PMA number: P100009
Supplement: S081
Product code: NKM
Generic name: Mitral valve repair devices
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