EXCLUDER BIFURCATED ENDOPROSTHESIS MANUFACTURED BY W.L. GORE & ASSOCIATES,INC

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Request for Information Form	Contact Information
Company Name	W.L. GORE & ASSOCIATES,INC
Address	1505 NORTH FOURTH ST.
City, State, Zip	FLAGSTAFF, AZ 86003
Country	US
FDA Owner/Operator Phone	302-738-4880
FDA Medical Specialty Code	CV - Cardiovascular
FDA Product Code	MIH
FDA Classification Name	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
FDA Device Classification Code	Premarket Approval
FDA Regulation Number	NULL
FDA Common Generic Name	AAA BIFURCATED ENDOPROSTHESIS
FDA Proprietary Device Name	EXCLUDER BIFURCATED ENDOPROSTHESIS
FDA Owner / Operator Number	9925013
FDA Owner / Operator Name	W. L. GORE & ASSOCIATES, INC.
FDA Establishment Registration Number	2017233
FDA Registered Establishment Name	W.L. GORE & ASSOCIATES,INC
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer MS - Specification Developer RR - Repackager/Relabeller
FDA Listing Date	04-25-05
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	COOK, INC. 750 DANIELS WAY PO BX 489 BLOOMINGTON, IN 47402 US 812-339-2235 / 812-339-2235	ZENITH (R) AAA ENDOVASCULAR GRAFT	ENDOVASCULAR GRAFT
2	ENDOLOGIX, INC. 11 STUDEBAKER IRVINE, CA 92618 US 949-595-7203 / 949-595-7203	POWERLINK SYSTEM	ENDOVASCULAR GRAFT
3	MEDTRONIC VASCULAR 3576 UNOCAL PL. SANTA ROSA, CA 95403 US 763-514-4000 / 707-566-1548	ANEURX STENT GRAFT SYSTEM	ABDOMINAL AORTIC STENT GRAFT
4	W. L. GORE & ASSOCIATES, INC. 1327 ORLEANS DR. SUNNYVALE, CA 94089 US 302-738-4880 / 520-526-3030 4473	EXCLUDER (TM) BIFURCATED ENDOPROSTHESIS	AAA BIFURCATED ENDOPROSTHESIS