PREMERE PFO CLOSURE SYSTEM MANUFACTURED BY ST. JUDE MEDICAL

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This company has been viewed 34 times within the past 60 days.

This product has been viewed: 23 times.

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	MLV
FDA Classification Name	OCCLUDER, TRANSCATHETER SEPTAL
FDA Device Classification Code
FDA Regulation Number	NULL
FDA Common Generic Name	SEPTAL CLOSURE DEVICE
FDA Proprietary Device Name	PREMERE PFO CLOSURE 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)
FDA Listing Date	12-18-06
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	CARDIA INC. 2900 LONE OAK PARKWAY SUITE 130 EAGAN, MN 55121 US 651-691-4100 / 651-691-4100	CARDIA PATENT FORAMEN OVALE CLOSURE SYSTEM, INTRASEPT PATENT FORAMEN OVALE CLOS	INTRASEPT, PFO CLOSURE DEVICE
2	CIERRA INC. 2761 FAIR OAKS AVE. REDWOOD CITY, CA 94063 US 650-298-4400 / 650-298-4414	PFX(TM) CATHETER	CARDIAC RADIO FREQUENCY CATHETER
3	NMT MEDICAL, INC. 27-43 WORMWOOD ST. BOSTON, MA 02210 US 617-737-0930 / 617-737-0930 407	CARDIOSEAL SEPTAL OCCLUSION SYSTEM	CARDIOSEAL
4	W.L. GORE & ASSOCIATES,INC 1505 NORTH FOURTH ST. FLAGSTAFF, AZ 86003 US 302-738-4880 / 928-864-4736	SEPTAL OCCLUDER	SEPTAL OCCLUDER