The following data is part of a premarket notification filed by Medtronic Ave, Inc. with the FDA for Medtronic Ave Bridge Stent.
| Device ID | K992569 |
| 510k Number | K992569 |
| Device Name: | MEDTRONIC AVE BRIDGE STENT |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MEDTRONIC AVE, INC. 2330A CIRCADIAN WAY Santa Rosa, CA 95407 -5415 |
| Contact | Susan Walton |
| Correspondent | Susan Walton MEDTRONIC AVE, INC. 2330A CIRCADIAN WAY Santa Rosa, CA 95407 -5415 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-02 |
| Decision Date | 1999-08-31 |
| Summary: | summary |