PMA P940016S024
- Device
- Heparin-Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System
- Applicant
- B. Braun Avitum AG
- PMA number
- P940016
- Supplement
- S024
- Product code
- MMY
- Decision date
- 2017-11-07
- Classification
- Lipoprotein, Low Density, Removal
- Generic name
- Lipoprotein, low density, removal
- Approval order statement
- Automate manufacturing processes related to the Ultrafilter, a component 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
- S024
- Product code
- MMY
- Generic name
- Lipoprotein, low density, removal
- Decision date
- 2017-11-07
- Decision code
- OK30
- Date received
- 2017-10-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Automate manufacturing processes related to the Ultrafilter, a component of the H.E.L.P. Futura Set.