PMA P100009S079

Device: MitraClip Delivery System
Applicant: ABBOTT MEDICAL
PMA number: P100009
Supplement: S079
Product code: NKM
Decision date: 2025-08-18
Classification: Cardiovascular
Generic name: Mitral valve repair devices
Approval order statement: to change the incoming inspection sampling plan for components of the TriClip and MitraClip Delivery Systems from an Attribute Acceptable Quality Limit (AQL) to a variable-based plan with custom sampling plan requirements

Current openFDA PMA Record#

Device: MitraClip Delivery System
Applicant: ABBOTT MEDICAL
PMA number: P100009
Supplement: S079
Product code: NKM
Generic name: Mitral valve repair devices
Decision date: 2025-08-18
Decision code: OK30
Date received: 2025-07-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to change the incoming inspection sampling plan for components of the TriClip and MitraClip Delivery Systems from an Attribute Acceptable Quality Limit (AQL) to a variable-based plan with custom sampling plan requirements