PMA P910018S042

Device: LIPOSORBER® LA-15 System
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S042
Product code: MMY
Decision date: 2026-06-16
Classification: Gastroenterology, Urology
Generic name: Lipoprotein, low density, removal
Approval order statement: a change in the acceptance criterion for the opening torque test performed during in-process inspection of the SULFLUX KP-05 filter the of LIPOSORBER LA-15 System

Current openFDA PMA Record#

Device: LIPOSORBER® LA-15 System
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S042
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 2026-06-16
Decision code: OK30
Date received: 2026-05-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change in the acceptance criterion for the opening torque test performed during in-process inspection of the SULFLUX KP-05 filter the of LIPOSORBER LA-15 System