PMA P910018S031

Device: LIPOSORBER LA-15 System
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S031
Product code: MMY
Decision date: 2021-07-28
Generic name: Lipoprotein, low density, removal
Approval order statement: Introduction of parametric release into the manufacturing process for the LIPOSORBER LA-15 LDL Adsorption Column which is a component device of the LIPOSORBER LA-15 System.

Current openFDA PMA Record#

Device: LIPOSORBER LA-15 System
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S031
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 2021-07-28
Decision code: OK30
Date received: 2021-06-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Introduction of parametric release into the manufacturing process for the LIPOSORBER LA-15 LDL Adsorption Column which is a component device of the LIPOSORBER LA-15 System.