De Novo
DEN150040: WallFlex Biliary RX Fully Covered Stent System RMV
FDA De Novo · boston scientific · decided Jun 3, 2016
Key facts
| De Novo number | DEN150040 |
|---|---|
| Device name | WallFlex Biliary RX Fully Covered Stent System RMV |
| Applicant | boston scientific |
| Product code | PNB |
| Date received | Aug 28, 2015 |
| Decision date | Jun 3, 2016 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Gastroenterology & Urology |
| FEI number | 3005099803 |
At a glance
- 1–9 Later 510(k)s citing this De Novo
- 10–99 UDI device identifiers (GUDID)
- 100–999 MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: