PMA P910018S035

Device: LIPOSORBER LA-15 System
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S035
Product code: MMY
Decision date: 2023-03-01
Classification: Gastroenterology, Urology
Generic name: Lipoprotein, low density, removal
Approval order statement: Change in quality control testing for the Liposorber LA-15 System regarding a change of gas chromatograph (GC) equipment for measurement of residual propanol.

Current openFDA PMA Record#

Device: LIPOSORBER LA-15 System
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S035
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 2023-03-01
Decision code: OK30
Date received: 2023-01-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change in quality control testing for the Liposorber LA-15 System regarding a change of gas chromatograph (GC) equipment for measurement of residual propanol.