PMA supplement
P940016 S021: HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM
FDA PMA supplement · Real-Time Process · B. Braun Avitum AG
Key facts
| Original PMA | P940016 |
|---|---|
| Supplement number | S021 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM |
| Generic name | Lipoprotein, low density, removal |
| Applicant | B. Braun Avitum AG |
| Product code | MMY |
| Received date | Jun 13, 2016 |
| Decision date | Sep 9, 2016 |
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: