PMA P940016S015

Device: H.E.L.P. PLASMAT FUTURA SYSTEM
Applicant: B. Braun Avitum AG
PMA number: P940016
Supplement: S015
Product code: MMY
Decision date: 2013-02-22
Classification: Lipoprotein, Low Density, Removal
Generic name: Lipoprotein, low density, removal
Approval order statement: APPROVAL FOR AN INCREASE IN MEMBRANE LENGTH AND AN INCREASE INHOUSING LENGTH OF THE HEPARIN ADSORBER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEPARIN ADSORBER 400 AND IS INDICATED FOR USE AS A COMPONENT OF THE H.E.L.P FUTURA APHERESIS SYSTEM, USED FOR THE REMOVAL, BY IONIC EXCHANGE, OF EXCESS HEPARIN ADDED TO PRECIPITATE LIPOPROTEINS FROM PLASMA.

Current openFDA PMA Record#

Device: H.E.L.P. PLASMAT FUTURA SYSTEM
Applicant: B. Braun Avitum AG
PMA number: P940016
Supplement: S015
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 2013-02-22
Decision code: APPR
Date received: 2012-12-20
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR AN INCREASE IN MEMBRANE LENGTH AND AN INCREASE INHOUSING LENGTH OF THE HEPARIN ADSORBER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEPARIN ADSORBER 400 AND IS INDICATED FOR USE AS A COMPONENT OF THE H.E.L.P FUTURA APHERESIS SYSTEM, USED FOR THE REMOVAL, BY IONIC EXCHANGE, OF EXCESS HEPARIN ADDED TO PRECIPITATE LIPOPROTEINS FROM PLASMA.