MULTIPLE MANUFACTURED BY BIOTRONIK GMBH & CO. KG

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MULTIPLE

Request for Information Form	Contact Information
Company Name	BIOTRONIK GMBH & CO. KG
Address	WOERMANNKEHRE 1
City, State, Zip	BERLIN,
Country	GM
FDA Owner/Operator Phone	49-30-689051200
FDA Medical Specialty Code	CV - Cardiovascular
FDA Product Code	DXY
FDA Classification Name	PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Device Classification Code	Premarket Approval
FDA Regulation Number	870.3610
FDA Common Generic Name	VARIOUS
FDA Proprietary Device Name	MULTIPLE
FDA Owner / Operator Number	9018331
FDA Owner / Operator Name	BIOTRONIK GMBH & CO. KG
FDA Establishment Registration Number	9610139
FDA Registered Establishment Name	BIOTRONIK GMBH & CO. KG
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	12-31-99
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of BIOTRONIK GMBH & CO. KG

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	BENCHMARK ELECTRONICS, INC. 4065 THEURER BLVD. WINONA, MN 55987 US 979-849-6550 / 507-453-4891	MEDTRONIC CARELINK PROGRAMMER MODEL 2090, 2067, 2290, 2091	IMPLANTABLE PACEMAKER PULSE GENERATOR PROGRAMMER
2	BIOTRONIK, INC. 6024 JEAN ROAD LAKE OSWEGO, OR 97035 US 888-345-0374 / 888-345-0374	MULTIPLE	VARIOUS
3	CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH ST. PAUL, MN 55112 US 651-582-4000 / 651-582-5656	MULTIPLE	PULSE GENERATOR, SSS
4	ELA MEDICAL S.A. 98-100 RUE MAURICE ARNOUX MONTROUGE, 92120 FR 331-496-55555 / 763-519-9408	MULTIPLE	PACEMAKER
5	GUIDANT - REDMOND 6645 185TH AVE. N.E. REDMOND, WA 98052 US 651-582-4000 / 651-582-5656	MULTIPLE	PULSE GENERATOR, SSS
6	GUIDANT IRELAND CASHEL RD. CLONMEL, TIPPERARY, EI 651-582-4000 / 651-582-5656	MULTIPLE	PULSE GENERATOR, SSS
7	MEDTRONIC B.V. EARL BAKKENSTRAAT 10 6422 PJ HEERLEN, 6422 PJ NL 763-514-4000 / 763-505-7831	MULTIPLE	IMPLANTABLE PULSE GENERATOR
8	MEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT 7000 CENTRAL AVE. N.E. MINNEAPOLIS, MN 55432 US 763-514-4000 / 763-505-7831	MULTIPLE	IMPLANTABLE PULSE GENERATOR
9	MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS, PR 00777 US 763-514-4000 / 763-505-7831	MULTIPLE	IMPLANTABLE PULSE GENERATOR
10	MEDTRONIC SWISS MANUFACTURING FACILITY ROUTE DU MOLLIAU 31 TOLOCHENAZ, 1131 SZ 763-514-4000 / 763-505-7831	MULTIPLE	IMPLANTABLE PULSE GENERATOR
11	ST. JUDE MEDICAL AB, CARDIAC RHYTHM MANAGEMENT DIV VEDDESTAVAGEN 19 JARFALLA, S-17584 SW 651-483-2000 / 818-362-6822	MULTIPLE	VARIOUS MODELS OF PULSE GENERATORS
12	ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 VALLEY VIEW CT. SYLMAR, CA 91342 US 651-483-2000 / 818-362-6822 2587		STERILE CARDIAC PACEMAKERS AND ACCESSORIES
13	ST. JUDE MEDICAL, PUERTO RICO, B.V. LOT 20-B ST. CAGUAS, PR 00725 US 651-483-2000 / 787-746-1111	MULTIPLE	STERILE CARDIAC PACEMAKERS AND ACCESSORIES
14	VITATRON B.V. MEANDER 1051 MJ ARNHEM, 6825 NL 763-514-4000 / 31-26-3767777	MULTIPLE	IMPLANTABLE PULSE GENERATOR

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