WallFlex Biliary RX Fully Covered Stent System RMV— 510(k) DEN150040
UnknownBoston Scientific
FDA 510(k) clearance DEN150040 for WallFlex Biliary RX Fully Covered Stent System RMV, Unknown on 2016-06-03. Applicant: Boston Scientific.
Clearance details
- Applicant
- Boston Scientific
- Product code
- Code PNB
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Marlboro, MA, US
Adverse events under product code PNB
product code PNB- Death
- 4
- Injury
- 132
- Total
- 136
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.