PMA P910018S040

Device: LIPOSORBER LA-15 System
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S040
Product code: MMY
Decision date: 2024-09-26
Classification: Gastroenterology, Urology
Generic name: Lipoprotein, low density, removal
Approval order statement: Change in synthesis tank, timing of column bioburden reduction operation, and process automation including gel transfer operation, adjustment operation for gell filling volume, cap attachment operation, appearance inspection for final product release, transfer of intermediate products between processes.

Current openFDA PMA Record#

Device: LIPOSORBER LA-15 System
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S040
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 2024-09-26
Decision code: OK30
Date received: 2024-08-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change in synthesis tank, timing of column bioburden reduction operation, and process automation including gel transfer operation, adjustment operation for gell filling volume, cap attachment operation, appearance inspection for final product release, transfer of intermediate products between processes.