PMA P910018S034

Device: LIPOSORBER LA-15 System
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S034
Product code: MMY
Decision date: 2022-06-30
Generic name: Lipoprotein, low density, removal
Approval order statement: This submission requests for a change in the material supplier of the NK-M3R(UL) which is a component device of the LIPOSORBER LA-15 System and one manufacturing process. The change is being made because the original supplier no longer produces the material.

Current openFDA PMA Record#

Device: LIPOSORBER LA-15 System
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S034
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 2022-06-30
Decision code: OK30
Date received: 2022-05-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: This submission requests for a change in the material supplier of the NK-M3R(UL) which is a component device of the LIPOSORBER LA-15 System and one manufacturing process. The change is being made because the original supplier no longer produces the material.