SPIDERX EMBOLIC PROTECTION DEVICE 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	NFA
FDA Classification Name	DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTECTION
FDA Device Classification Code	Standards
FDA Regulation Number	870.1250
FDA Common Generic Name	EMBOLIC PROTECTION DEVICE
FDA Proprietary Device Name	SPIDERX EMBOLIC PROTECTION DEVICE
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	08-03-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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1	ACCELLENT INC. 1526-6 CALLE HERTZ JUAREZ, CHIHUAHUA, 32470 MX 866-899-1392 / 915-782-1944	FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM	PERCUTANEOUS CATHETER
2	BOSTON SCIENTIFIC CORP. 2011 STIERLIN CT. MOUNTAIN VIEW, CA 94043 US 508-652-5594 / 508-652-5594	MULTIPLE	VARIOUS TYPES OF EMBOLIC PROTECTION DEVICES
3	KENSEY NASH CORP. 735 PENNSYLVANIA DRIVE EXTON, PA 19341 US 484-713-2100 / 484-713-2146	TRIACTIV SYSTEM	EMBOLIC PROTECTION DEVICE
4	LUMEN BIOMEDICAL, INC. 14505 21ST AVE. NORTH SUITE 212 PLYMOUTH, MN 55447 US 763-577-9600 / 763-746-9551	FIBERNET EMBOLI CAPTURE SYSTEM	PERCUTANEOUS CATHETER
5	MEDTRONIC VASCULAR 35-37A CHERRY HILL DR DANVERS, MA 01923 US 763-514-4000 / 978-777-0042	GUARDWIRE PLUS	DISTAL PROTECTION SYSTEM
6	ST. JUDE MEDICAL 6550 WEDGWOOD RD. NORTH SUITE 150 MAPLE GROVE, MN 55311 US 651-483-2000 / 763-383-2639	PROXIS EMBOLIC PROTECTION SYSTEM, PROXIS FLOW CONTROL SYSTEM	EMBOLIC PROTECTION SYSTEM, FLOW CONTROL SYSTEM