PMA P910018S021

Device: LIPOSORBER(R) LA-15 SYSTEM
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S021
Product code: MMY
Decision date: 2016-10-14
Classification: Lipoprotein, Low Density, Removal
Generic name: Lipoprotein, low density, removal
Approval order statement: Approval for modifications to the instructions for use, operator's manual, and the patient guide for the LIPOSORBER® LA-15 System for familial hypercholesterolemia and integration of instructions for use for the LIPOSORBER® LA-15 System for familial hypercholesterolemia and focal segmental glomerulosclerosis.

Current openFDA PMA Record#

Device: LIPOSORBER(R) LA-15 SYSTEM
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S021
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 2016-10-14
Decision code: APPR
Date received: 2016-07-29
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for modifications to the instructions for use, operator's manual, and the patient guide for the LIPOSORBER® LA-15 System for familial hypercholesterolemia and integration of instructions for use for the LIPOSORBER® LA-15 System for familial hypercholesterolemia and focal segmental glomerulosclerosis.