PMA P940016S011
- Device
- PLASMAT SECURA HEPARIN-INDUCED EXTRACORPOREAL LDL APHERESIS SYSTEM (H.E.L.P.)
- Applicant
- B. Braun Avitum AG
- PMA number
- P940016
- Supplement
- S011
- Product code
- MMY
- Decision date
- 2009-04-20
- Classification
- Lipoprotein, Low Density, Removal
- Generic name
- Lipoprotein, low density, removal
- Approval order statement
- APPROVAL FOR AN EXTENSION OF SHELF-LIFE FROM 5 YEARS TO 6 YEARS FOR THE PRECIPITATE FILTER COMPONENT OF THE DEVICE.
Current openFDA PMA Record#
- Device
- PLASMAT SECURA HEPARIN-INDUCED EXTRACORPOREAL LDL APHERESIS SYSTEM (H.E.L.P.)
- Applicant
- B. Braun Avitum AG
- PMA number
- P940016
- Supplement
- S011
- Product code
- MMY
- Generic name
- Lipoprotein, low density, removal
- Decision date
- 2009-04-20
- Decision code
- APPR
- Date received
- 2009-02-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN EXTENSION OF SHELF-LIFE FROM 5 YEARS TO 6 YEARS FOR THE PRECIPITATE FILTER COMPONENT OF THE DEVICE.