PMA P910018S022

Device: LIPOSORBER(R) LA-15 SYSTEM
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S022
Product code: MMY
Decision date: 2017-05-23
Classification: Lipoprotein, Low Density, Removal
Generic name: Lipoprotein, low density, removal
Approval order statement: Approval for changes to the housing of adsorption column LA-15 and connector parts of tubing system NK-M3R(U), plus components of the LIPOSORBER® LA-15 System.

Current openFDA PMA Record#

Device: LIPOSORBER(R) LA-15 SYSTEM
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S022
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 2017-05-23
Decision code: APPR
Date received: 2017-03-31
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for changes to the housing of adsorption column LA-15 and connector parts of tubing system NK-M3R(U), plus components of the LIPOSORBER® LA-15 System.