MULTIPLE MANUFACTURED BY ST. JUDE MEDICAL, PUERTO RICO, B.V.

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MULTIPLE

Request for Information Form	Contact Information
Company Name	ST. JUDE MEDICAL, PUERTO RICO, B.V.
Address	LOT 20-B ST.
City, State, Zip	CAGUAS, PR 00725
Country	US
FDA Owner/Operator Phone	651-483-2000
FDA Medical Specialty Code	CV - Cardiovascular
FDA Product Code	DTB
FDA Classification Name	ELECTRODE, PACEMAKER, PERMANENT
FDA Device Classification Code	Premarket Approval
FDA Regulation Number	870.3680
FDA Common Generic Name	VARIOUS MODELS OF IMPLANTABLE CARDIAC LEADS & ACCESSORIES
FDA Proprietary Device Name	MULTIPLE
FDA Owner / Operator Number	2126673
FDA Owner / Operator Name	ST. JUDE MEDICAL, INC.
FDA Establishment Registration Number	2648612
FDA Registered Establishment Name	ST. JUDE MEDICAL, PUERTO RICO, B.V.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	12-23-05
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of ST. JUDE MEDICAL, PUERTO RICO, B.V.

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	ARROW INTL., INC. 312 COMMERCE PL. ASHEBORO, NC 27203 US 610-378-0131 / 610-378-0131		TEMPORARY PALING CATHETERS
2	BIOTRONIK GMBH & CO. KG WOERMANNKEHRE 1 BERLIN, D-12359 GM 49-30-689051200 / 877-737-2010 2136	MULTIPLE	VARIOUS
3	BIOTRONIK, INC. 6024 JEAN ROAD LAKE OSWEGO, OR 97035 US 888-345-0374 / 888-345-0374	MULTIPLE	VARIOUS
4	CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH ST. PAUL, MN 55112 US 651-582-4000 / 651-582-5656	MULTIPLE	VARIOUS MODELS OF IMPLANTABLE LEADS
5	EDWARDS LIFESCIENCES AG PARQUE INDUSTRIAL ITABO KM. 18.5 CARR. SANCHEZ HAINA, SAN CRISTOBAL, DR 949-250-2500 / 949-250-2698	ELECTRODE, PACEMAKER, PERMANENT	ELECTRODE, PACEMAKER, PERMANENT
6	EDWARDS LIFESCIENCES TECHNOLOGY SARL STATE RD. 402 N.KM 1.4 ANASCO, PR 00610 US 949-250-2500 / 949-250-2698	ELECTRODE, PACEMAKER, PERMANENT	ELECTRODE, PACEMAKER, PERMANENT
7	EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY IRVINE, CA 92614 US 949-250-2500 / 949-250-2698	ELECTRODE, PACEMAKER, PERMANENT	ELECTRODE, PACEMAKER, PERMANENT
8	ELA MEDICAL S.A. 98-100 RUE MAURICE ARNOUX MONTROUGE, 92120 FR 331-496-55555 / 763-519-9408	ELECTRODE, PACEMAKER, PERMANENT (MULTIPLE BRANDS)	VARIOUS PACEMAKER LEADS
9	GUIDANT IRELAND CASHEL RD. CLONMEL, TIPPERARY, EI 651-582-4000 / 651-582-5656	MULTIPLE	VARIOUS MODELS OF IMPLANTABLE LEADS
10	GUIDANT PUERTO RICO B.V. #12, RD. #698 DORADO, PR 00646 US 651-582-4000 / 651-582-5656	MULTIPLE	VARIOUS MODELS OF IMPLANTABLE LEADS
11	MEDTRONIC B.V. EARL BAKKENSTRAAT 10 6422 PJ HEERLEN, 6422 PJ NL 763-514-4000 / 763-505-7831	MULTIPLE	TEMPORARY & PERMANENT CARDIAC PACING LEADS
12	MEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT 7000 CENTRAL AVE. N.E. MINNEAPOLIS, MN 55432 US 763-514-4000 / 763-505-7831	MULTIPLE	TEMPORARY & PERMANENT CARDIAC PACING LEADS
13	MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA RD. 149, KM. 56.3 CALL BOX 6001 VILLALBA, PR 00766 US 763-514-4000 / 763-505-7831	MULTIPLE	TEMPORARY & PERMANENT CARDIAC PACING LEADS
14	MIGADA PLANT NORTH INDUSTRIAL ZONE KIRYAT SHMONA, 10258 IS 972-9-8631515 / 972-4-6908826	ABG-I.V. LAB SITE	LAB SITE
15	OSCOR CARIBE LLC ZONA FRANCA LAS AMERICAS NAVE I-2 SANTO DOMINGO, DR 727-937-2511 133 / 727-937-2511 133	VARIOUS	PERMANENT PACING LEADS
16	OSCOR INC. 3816 DE SOTO BLVD. PALM HARBOR, FL 34683 US 727-937-2511 133 / 727-937-2511	PERMANENT PACING LEADS	VARIOUS MODELS OF STERILE PERMANENT PACING LEADS
17	SOMEDICS 87, ROUTE DE GRIGNY RIS ORANGIS, 91130 FR 011- 33-169430888 / 727-942-1122	SOMEDICS	PERMANENT PACING LEAD
18	SORIN BIOMEDICA C.R.M., S.R.L. VIA CRESCENTINO S.N. SALUGGIA VC, 13040 IT 390-161-487539 / 763-519-9408	MULTIPLE	PACEMAKER LEAD
19	ST. JUDE MEDICAL AB, CARDIAC RHYTHM MANAGEMENT DIV VEDDESTAVAGEN 19 JARFALLA, S-17584 SW 651-483-2000 / 818-362-6822	MULTIPLE	VARIOUS MODELS OF CARDIAC PACING LEADS
20	ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 VALLEY VIEW CT. SYLMAR, CA 91342 US 651-483-2000 / 818-362-6822 2587	MULTIPLE	VARIOUS MODELS OF IMPLANTABLE CARDIAC LEADS & ACCESSORIES
21	SURGICRAFT LTD. 16 THE OAKS, CLEWS RD REDDITCH, WORCESTERSHIRE, B98 7ST UK 44-152-7512600 / 44-152-7555893	SURGICRAFT PACEMAKER ELECTRODE	SURGICRAFT PACEMAKER ELECTRODE
22	VASCOMED INSTITUT FUR KATHETERTECHNOLOGIE GMBH HERTZALLEE 1 BINZEN, D79589 GM 011-49-7621570900 / 727-942-1122	VASCO (VARIOUS)	PERMANENT PACING LEAD
23	VASCOR MEDICAL CORP. 4634 TARAY LANE HOLIDAY, FL 34690 US 727-942-1122 / 727-942-1122		PERMANENT PACING LEAD