The following data is part of a premarket notification filed by Medtronic Ave, Inc. with the FDA for Medtronic Ave Bridge Constant Biliary Stent System Or ('constant.
| Device ID | K030633 |
| 510k Number | K030633 |
| Device Name: | MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MEDTRONIC AVE, INC. 3576 UNOCAL PL. Santa Rosa, CA 95403 |
| Contact | Sarah Sheppard |
| Correspondent | Sarah Sheppard MEDTRONIC AVE, INC. 3576 UNOCAL PL. Santa Rosa, CA 95403 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-28 |
| Decision Date | 2003-09-02 |
| Summary: | summary |