PMA P910018S027

Device: LIPOSORBER LA-15 System
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S027
Product code: MMY
Decision date: 2020-04-21
Generic name: Lipoprotein, low density, removal
Approval order statement: Approval for modification to the indications for use statement to include a new Group D - "Functional Hypercholesterolemic Heterozygotes with LDL-C >= 100 mg/dl and lipoprotein(a) [Lp(a)] >= 60 mg/dL, and either documented coronary artery disease or documented peripheral artery disease."

Current openFDA PMA Record#

Device: LIPOSORBER LA-15 System
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S027
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 2020-04-21
Decision code: APPR
Date received: 2019-08-13
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for modification to the indications for use statement to include a new Group D - "Functional Hypercholesterolemic Heterozygotes with LDL-C >= 100 mg/dl and lipoprotein(a) [Lp(a)] >= 60 mg/dL, and either documented coronary artery disease or documented peripheral artery disease."