PMA P940016S027

Device: H.E.L.P. Futura Apheresis System
Applicant: B. Braun Avitum AG
PMA number: P940016
Supplement: S027
Product code: MMY
Decision date: 2019-06-07
Classification: Lipoprotein, Low Density, Removal
Generic name: Lipoprotein, low density, removal
Approval order statement: Approval for a change in the cutting process in the manufacturing of the H.E.L.P. Ultrafilter HI PS 20 included in the H.E.L.P. Futura Set.

Current openFDA PMA Record#

Device: H.E.L.P. Futura Apheresis System
Applicant: B. Braun Avitum AG
PMA number: P940016
Supplement: S027
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 2019-06-07
Decision code: APPR
Date received: 2018-09-28
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a change in the cutting process in the manufacturing of the H.E.L.P. Ultrafilter HI PS 20 included in the H.E.L.P. Futura Set.