INTRACOIL SELF-EXPANDING PERIPHERAL STENT 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	NIP
FDA Classification Name	STENT, SUPERFICIAL FEMORAL ARTERY
FDA Device Classification Code	Premarket Approval
FDA Regulation Number	NULL
FDA Common Generic Name	FEMOROPOPLITEAL STENT
FDA Proprietary Device Name	INTRACOIL SELF-EXPANDING PERIPHERAL STENT
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	04-29-05
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 VASCULAR-VASCULAR SOLUTIONS 26531 YNEZ RD. TEMECULA, CA 92589 US 847-937-6100 / 847-938-3471	RX HERCULINK,OMNILINK,DYNALINK,ABSOLUTE,AND MEGALINK	STERILE PERIPHERAL STENT
2	ADMEDES SCHUESSLER GMBH RASTATTER STRASSE 15 PFORZHEIM, 75179 GM 49-723-1922310 / 49-723-1922310	STENT, SUPERFICIAL FEMORAL ARTERY	SUPERFICIAL FEMORAL ARTERY STENT
3	EV3 CORPORATION 9401 73RD AVE, NORTH SUITE 300 BROOKLYN PARK, MN 55428 US 763-398-7000 / 763-397-7546	INTRACOIL SELF-EXPANDING PERIPHERAL STENT	FEMOROPOPLITEAL STENT
4	EV3 INC 651 CAMPUS DR. ST. PAUL, MN 55112 US 651-697-9797 / 763-398-7546	INTRACOIL PERIPHERAL SELF-EXPANDING STENT	FEMOROPOPLITEAL STENT
5	W.L. GORE & ASSOCIATES,INC 1505 NORTH FOURTH ST. FLAGSTAFF, AZ 86003 US 302-738-4880 / 928-864-4736	GORE VIABAHN ENDOPROSTHESIS	VASCULAR ENDOPROSTHESIS