PMA supplement
P940016 S012: PLASMAT SECURA HEPARIN-INDUCED EXTRACORPOREAL LDL APHERESIS SYSTEM (H.E.L.P.)
FDA PMA supplement · Real-Time Process · B. Braun Avitum AG
Key facts
| Original PMA | P940016 |
|---|---|
| Supplement number | S012 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | PLASMAT SECURA HEPARIN-INDUCED EXTRACORPOREAL LDL APHERESIS SYSTEM (H.E.L.P.) |
| Generic name | Lipoprotein, low density, removal |
| Applicant | B. Braun Avitum AG |
| Product code | MMY |
| Received date | Feb 19, 2009 |
| Decision date | Apr 20, 2009 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: