PMA P940016S014

Device: HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM
Applicant: B. Braun Avitum AG
PMA number: P940016
Supplement: S014
Product code: MMY
Decision date: 2012-01-13
Classification: Lipoprotein, Low Density, Removal
Generic name: Lipoprotein, low density, removal
Approval order statement: APPROVAL FOR A CHANGE IN THE POTTING RESIN USED TO ANCHOR THE MEMBRANES OF THE HEPARIN ADSORBER AND THE PLASMAFILTER HAEMOSELECT COMPONENTS OF THE SYSTEM.

Current openFDA PMA Record#

Device: HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM
Applicant: B. Braun Avitum AG
PMA number: P940016
Supplement: S014
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 2012-01-13
Decision code: APPR
Date received: 2011-07-19
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE IN THE POTTING RESIN USED TO ANCHOR THE MEMBRANES OF THE HEPARIN ADSORBER AND THE PLASMAFILTER HAEMOSELECT COMPONENTS OF THE SYSTEM.