PMA P940016S026

Device: Heparin-Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System
Applicant: B. Braun Avitum AG
PMA number: P940016
Supplement: S026
Product code: MMY
Decision date: 2019-05-22
Classification: Lipoprotein, Low Density, Removal
Generic name: Lipoprotein, low density, removal
Approval order statement: Approval to change the test method for Total Blood Volume (TBV) and to remove TBV acceptance criteria for the batch release of the H.E.L.P. Ultrafilter HIPS 20.

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: S026
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 2019-05-22
Decision code: APPR
Date received: 2018-06-15
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to change the test method for Total Blood Volume (TBV) and to remove TBV acceptance criteria for the batch release of the H.E.L.P. Ultrafilter HIPS 20.