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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K030633
Device Name MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT
Applicant
Medtronic Ave, Inc.
3576 Unocal Pl.
Santa Rosa,  CA  95403
Applicant Contact SARAH SHEPPARD
Correspondent
Medtronic Ave, Inc.
3576 Unocal Pl.
Santa Rosa,  CA  95403
Correspondent Contact SARAH SHEPPARD
Regulation Number876.5010
Classification Product Code
FGE  
Date Received02/28/2003
Decision Date 09/02/2003
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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