PMA P940016S016

Device
H.E.L.P. PLASMAT FUTURA SYSTEM
Applicant
B. Braun Avitum AG
PMA number
P940016
Supplement
S016
Product code
MMY
Decision date
2015-08-11
Classification
Lipoprotein, Low Density, Removal
Generic name
Lipoprotein, low density, removal
Approval order statement
APPROVAL FOR THE H.E.L.P. OPTIMIZED THERAPY (HOT) CONFIGURATION

Current openFDA PMA Record#

Device
H.E.L.P. PLASMAT FUTURA SYSTEM
Applicant
B. Braun Avitum AG
PMA number
P940016
Supplement
S016
Product code
MMY
Generic name
Lipoprotein, low density, removal
Decision date
2015-08-11
Decision code
APPR
Date received
2013-09-13
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE H.E.L.P. OPTIMIZED THERAPY (HOT) CONFIGURATION