PMA P940016S017
- Device
- HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.)FUTURA APHERESIS SYSTEM
- Applicant
- B. Braun Avitum AG
- PMA number
- P940016
- Supplement
- S017
- Product code
- MMY
- Decision date
- 2015-06-15
- Classification
- Lipoprotein, Low Density, Removal
- Generic name
- Lipoprotein, low density, removal
- Approval order statement
- PROPOSED REDUCTION OF CONTROLS PERFORMED AT THE END OF EACH BATCH.
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
- S017
- Product code
- MMY
- Generic name
- Lipoprotein, low density, removal
- Decision date
- 2015-06-15
- Decision code
- OK30
- Date received
- 2015-05-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- PROPOSED REDUCTION OF CONTROLS PERFORMED AT THE END OF EACH BATCH.