PMA P910018S041

Device: LIPOSORBER® LA-15 System
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S041
Product code: MMY
Decision date: 2026-03-30
Classification: Gastroenterology, Urology
Generic name: Lipoprotein, low density, removal
Approval order statement: Approval for a change in the supplier of the lubricant, calcium stearate, added to the polyethylene resin used in the manufacture of the hollow fiber of the device.

Current openFDA PMA Record#

Device: LIPOSORBER® LA-15 System
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S041
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 2026-03-30
Decision code: APPR
Date received: 2026-01-14
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a change in the supplier of the lubricant, calcium stearate, added to the polyethylene resin used in the manufacture of the hollow fiber of the device.