PMA P910018S037

Device: LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S037
Product code: MMY
Decision date: 2025-03-05
Classification: Gastroenterology, Urology
Generic name: Lipoprotein, low density, removal
Approval order statement: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of the above referenced premarket approval application (PMA) 180-day supplement(s)/75-day humanitarian device exemption (HDE) supplement(s), which requested approval for packaging material (the shape of the cap, removing one material (styrene elastomer) from the cap, and the welding of the cap to the device), labeling, and a new sterilization site at Kaneka Corporation Tomatoh Plant Tomakomai, Hokkaido, 059-1362 Japan.

Current openFDA PMA Record#

Device: LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S037
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 2025-03-05
Decision code: APPR
Date received: 2024-07-26
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of the above referenced premarket approval application (PMA) 180-day supplement(s)/75-day humanitarian device exemption (HDE) supplement(s), which requested approval for packaging material (the shape of the cap, removing one material (styrene elastomer) from the cap, and the welding of the cap to the device), labeling, and a new sterilization site at Kaneka Corporation Tomatoh Plant Tomakomai, Hokkaido, 059-1362 Japan.