PMA P910018S025

Device: Liposorber LA-15 System
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S025
Product code: MMY
Decision date: 2018-04-12
Classification: Lipoprotein, Low Density, Removal
Generic name: Lipoprotein, low density, removal
Approval order statement: Change to the bioburden recovery procedure of the sterilization process used for the SULFLUX® KP-05 plasma filter device, a component of the LIPOSORBER® LA-15 System.

Current openFDA PMA Record#

Device: Liposorber LA-15 System
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S025
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 2018-04-12
Decision code: OK30
Date received: 2018-03-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to the bioburden recovery procedure of the sterilization process used for the SULFLUX® KP-05 plasma filter device, a component of the LIPOSORBER® LA-15 System.