PMA P940016S025
- Device
- H.E.L.P. Futura Apheresis System
- Applicant
- B. Braun Avitum AG
- PMA number
- P940016
- Supplement
- S025
- Product code
- MMY
- Decision date
- 2018-06-28
- Classification
- Lipoprotein, Low Density, Removal
- Generic name
- Lipoprotein, low density, removal
- Approval order statement
- Change to the fiber bundle 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
- S025
- Product code
- MMY
- Generic name
- Lipoprotein, low density, removal
- Decision date
- 2018-06-28
- Decision code
- OK30
- Date received
- 2018-06-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the fiber bundle of the H.E.L.P. Ultrafilter HI PS 20 included in the H.E.L.P. Futura Set.