PMA P100009S074

Device: MitraClip G4 Clip Delivery System; MitraClip G5 Delivery System
Applicant: ABBOTT MEDICAL
PMA number: P100009
Supplement: S074
Product code: NKM
Decision date: 2025-05-18
Classification: Cardiovascular
Generic name: Mitral valve repair devices
Approval order statement: a change in the incoming inspection requirement for functional inspection points for a subassembly component used in the manufacture of the MitraClip and TriClip clip delivery systems (CDS)

Current openFDA PMA Record#

Device: MitraClip G4 Clip Delivery System; MitraClip G5 Delivery System
Applicant: ABBOTT MEDICAL
PMA number: P100009
Supplement: S074
Product code: NKM
Generic name: Mitral valve repair devices
Decision date: 2025-05-18
Decision code: OK30
Date received: 2025-04-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change in the incoming inspection requirement for functional inspection points for a subassembly component used in the manufacture of the MitraClip and TriClip clip delivery systems (CDS)