PROXIS EMBOLIC PROTECTION SYSTEM, PROXIS FLOW CONTROL SYSTEM MANUFACTURED BY ST. JUDE MEDICAL

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Request for Information Form	Contact Information
Company Name	ST. JUDE MEDICAL
Address	6550 WEDGWOOD RD. NORTH SUITE 150
City, State, Zip	MAPLE GROVE, MN 55311
Country	US
FDA Owner/Operator Phone	651-483-2000
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 SYSTEM, FLOW CONTROL SYSTEM
FDA Proprietary Device Name	PROXIS EMBOLIC PROTECTION SYSTEM, PROXIS FLOW CONTROL SYSTEM
FDA Owner / Operator Number	2126673
FDA Owner / Operator Name	ST. JUDE MEDICAL, INC.
FDA Establishment Registration Number	3004028841
FDA Registered Establishment Name	ST. JUDE MEDICAL
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date	04-16-03
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.

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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	EV3 INC. 4600 NATHAN LN. NORTH PLYMOUTH, MN 55442 US 763-398-7000 / 763-398-7546	SPIDERX EMBOLIC PROTECTION DEVICE	EMBOLIC PROTECTION DEVICE
4	KENSEY NASH CORP. 735 PENNSYLVANIA DRIVE EXTON, PA 19341 US 484-713-2100 / 484-713-2146	TRIACTIV SYSTEM	EMBOLIC PROTECTION DEVICE
5	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
6	MEDTRONIC VASCULAR 35-37A CHERRY HILL DR DANVERS, MA 01923 US 763-514-4000 / 978-777-0042	GUARDWIRE PLUS	DISTAL PROTECTION SYSTEM