PMA P910018S019

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: S019
Product code: MMY
Decision date: 2016-04-19
Classification: Lipoprotein, Low Density, Removal
Generic name: Lipoprotein, low density, removal
Approval order statement: Implementation of a new manufacturing site for the vendor [Neat Co., Ltd.] of the GD cap component of the SULFLUX® KP-05 as part of the LIPOSORBER® LA-15 System.

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: S019
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 2016-04-19
Decision code: OK30
Date received: 2016-04-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of a new manufacturing site for the vendor [Neat Co., Ltd.] of the GD cap component of the SULFLUX® KP-05 as part of the LIPOSORBER® LA-15 System.