PMA P910018S018

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: S018
Product code: MMY
Decision date: 2016-03-10
Classification: Lipoprotein, Low Density, Removal
Generic name: Lipoprotein, low density, removal
Approval order statement: Change of vendor (and manufacturing site) of brominated polycarbonate for the housing and header components in the LIPOSORBER LA-15 System’s SULFLUX KP-05.

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: S018
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 2016-03-10
Decision code: OK30
Date received: 2016-02-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change of vendor (and manufacturing site) of brominated polycarbonate for the housing and header components in the LIPOSORBER LA-15 System’s SULFLUX KP-05.