PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS MANUFACTURED BY EV3 INC.

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Request for Information Form	Contact Information
Company Name	EV3 INC.
Address	4600 NATHAN LN. NORTH
City, State, Zip	PLYMOUTH, MN 55442
Country	US
FDA Owner/Operator Phone	763-398-7000
FDA Medical Specialty Code	CV - Cardiovascular
FDA Product Code	NIM
FDA Classification Name	STENT, CAROTID
FDA Device Classification Code	Premarket Approval
FDA Regulation Number	NULL
FDA Common Generic Name	CAROTID STENT
FDA Proprietary Device Name	PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS
FDA Owner / Operator Number	9025796
FDA Owner / Operator Name	EV3 INC.
FDA Establishment Registration Number	2183870
FDA Registered Establishment Name	EV3 INC.
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer MS - Specification Developer RR - Repackager/Relabeller
FDA Listing Date	01-31-07
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	ABBOTT IRELAND VASCULAR DIVISION MERVUE BUSINESS PARK GALWAY, EI 847-937-6100 / 847-938-3471	XACT CARTOID STENT SYSTEM	CARTOID STENT
2	ABBOTT VASCULAR-VASCULAR SOLUTIONS 3200 LAKESIDE DR. SANTA CLARA, CA 95054 US 847-937-6100 / 847-938-3471	RX ACCULINK CAROTID STENT SYSTEM	CAROTID STENT
3	ABBOTT VASCULAR-VASCULAR SOLUTIONS 26531 YNEZ RD. TEMECULA, CA 92589 US 847-937-6100 / 847-938-3471	RX ACCULINK CAROTID STENT SYSTEM	CAROTID STENT
4	ADMEDES SCHUESSLER GMBH RASTATTER STRASSE 15 PFORZHEIM, 75179 GM 49-723-1922310 / 49-723-1922310	XACT	CAROTID STENT
5	BOSTON SCIENTIFIC CORP. 10231 BUBB RD. CUPERTINO, CA 95014 US 508-652-5594 / 508-652-5594	NEXSTENT CAROTID STENT AND DELIVERY SYSTEM	CAROTID STENT AND DELIVERY SYSTEM(OTW AND MONORAIL)
6	CORDIS DE MEXICO, S.A. DE C.V. CIRCUITO INTERIOR NORTE #1820 PARQUE INDUSTRIAL SALVARCAR CD. JUAREZ, CHIHUAHUA, 32580 MX 786-313-2000 / 908-412-3065	PRECISE NITINOL STENT SYSTEM	STERILE CAROTID STENTS
7	INSITU TECHNOLOGIES, INC. 5810 BLACKSHIRE PATH INVER GROVE HEIGHTS, MN 55076 US 651-389-1017 / 651-389-1017	DIAMONDBACK RENAL STENT, DIAMONDBACK II RENAL STENT	RENAL STENT