PMA P940016S021

Device: HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM
Applicant: B. Braun Avitum AG
PMA number: P940016
Supplement: S021
Product code: MMY
Decision date: 2016-09-09
Classification: Lipoprotein, Low Density, Removal
Generic name: Lipoprotein, low density, removal
Approval order statement: Approval for changes in primary packaging of the H.E.L.P. Futura Set and individually packed filters.

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: S021
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 2016-09-09
Decision code: APPR
Date received: 2016-06-13
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for changes in primary packaging of the H.E.L.P. Futura Set and individually packed filters.