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510(k) Premarket Notification Database

Device Classification Name:	CATHETER, BILIARY
Regulation Number:	876.5010 [See Other Products with this regulation number]
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
Contact:	SARAH SHEPPARD
Product Code:	FGE [See Other Manufacturers that make this Product]
Date Received:	02-28-2003
Decision Date:	09-02-2003
Decision:	SU
Advisory Committee:	GU
Statement/Summary/Purged Status:	Summary
Type:	Traditional
Review by Third Party:	N
Expedited Review:	N

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