The following data is part of a premarket notification filed by Medtronic Ave, Inc. with the FDA for Medtronic Ave Bridge Aurora Biliary Stent System (aurora).
| Device ID | K030839 |
| 510k Number | K030839 |
| Device Name: | MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA) |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MEDTRONIC AVE, INC. 3576 Unocal Place Santa Rosa, CA 95403 |
| Contact | Marlene Cobb-carlson |
| Correspondent | Marlene Cobb-carlson MEDTRONIC AVE, INC. 3576 Unocal Place Santa Rosa, CA 95403 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-17 |
| Decision Date | 2003-05-30 |
| Summary: | summary |