The following data is part of a De Novo classification by Boston Scientific with the FDA for Wallflex Biliary Rx Fully Covered Stent System Rmv.
| DeNovo ID | DEN150040 |
| Device Name: | WallFlex Biliary RX Fully Covered Stent System RMV |
| Classification | Biliary Stent System For Benign Strictures |
| Applicant | BOSTON SCIENTIFIC 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Thomas Hirte |
| Product Code | PNB |
| CFR Regulation Number | 876.5011 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Gastroenterology/Urology |
| Classification Advisory | Gastroenterology/Urology |
| Type | Direct |
| Date Received | 2015-08-28 |
| Decision Date | 2016-06-03 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08714729953197 | DEN150040 | 000 |
| 08714729953180 | DEN150040 | 000 |
| 08714729953173 | DEN150040 | 000 |
| 08714729953166 | DEN150040 | 000 |
| 08714729953159 | DEN150040 | 000 |