PMA
P940016: H.E.L.P. SYSTEM
FDA PMA · Lipoprotein, low density, removal · B. Braun Avitum AG
Key facts
| PMA number | P940016 |
|---|---|
| Trade name | H.E.L.P. SYSTEM |
| Generic name | Lipoprotein, low density, removal |
| Applicant | B. Braun Avitum AG |
| Owner/operator | B. BRAUN Avitum AG |
| Product code | MMY |
| Approval date | Sep 19, 1997 |
| Docket number | 98M-0138 |
| Notice date | Apr 16, 1998 |
| Establishment registration | 3007007791 |
| FEI number | 3007007791 |
At a glance
- 10–99 Supplements
- Jun 7, 2019 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: