PMA P940016S023

Device: Heparin_Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System
Applicant: B. Braun Avitum AG
PMA number: P940016
Supplement: S023
Product code: MMY
Decision date: 2017-07-06
Classification: Lipoprotein, Low Density, Removal
Generic name: Lipoprotein, low density, removal
Approval order statement: Qualification of an additional clean room area for the B. Braun Avitum Italy Plant for the manufacturing of the H.E.L.P Futura Set.

Current openFDA PMA Record#

Device: Heparin_Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System
Applicant: B. Braun Avitum AG
PMA number: P940016
Supplement: S023
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 2017-07-06
Decision code: OK30
Date received: 2017-06-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Qualification of an additional clean room area for the B. Braun Avitum Italy Plant for the manufacturing of the H.E.L.P Futura Set.