ELECTRODE, PACEMAKER, TEMPORARY MANUFACTURED BY EDWARDS LIFESCIENCES TECHNOLOGY SARL

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ELECTRODE, PACEMAKER, TEMPORARY

Request for Information Form	Contact Information
Company Name	EDWARDS LIFESCIENCES TECHNOLOGY SARL
Address	STATE RD. 402 N.KM 1.4
City, State, Zip	ANASCO, PR 00610
Country	US
FDA Owner/Operator Phone	949-250-2500
FDA Medical Specialty Code	CV - Cardiovascular
FDA Product Code	LDF
FDA Classification Name	ELECTRODE, PACEMAKER, TEMPORARY
FDA Device Classification Code	Standards
FDA Regulation Number	870.3680
FDA Common Generic Name	ELECTRODE, PACEMAKER, TEMPORARY
FDA Proprietary Device Name	ELECTRODE, PACEMAKER, TEMPORARY
FDA Owner / Operator Number	9040666
FDA Owner / Operator Name	EDWARDS LIFESCIENCES, LLC.
FDA Establishment Registration Number	2648045
FDA Registered Establishment Name	EDWARDS LIFESCIENCES TECHNOLOGY SARL
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	11-21-00
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of EDWARDS LIFESCIENCES TECHNOLOGY SARL

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	AESCULAP AG & CO. KG. AM AESCULAP PLATZ TUTTLINGEN, DONAU, D-78532 GM 49-74-6195-1548 / 610-984-9074	STEELTEX ELECTRODE SET	ELECTRODE
2	ALPHA MEDICAL INSTRUMENTS LLC 23455 MADERO SUITE B MISSION VIEJO, CA 92691 US 949-460-0944 / 949-460-0944	ALPHA BIPOLAR PACING CATHETER	STERILE TEMPORARY PACING CATHETER
3	ALTO DEVELOPMENT CORP. 5206 ASBURY RD. FARMINGDALE, NJ 07727 US 732-938-2266 / 732-938-2266	MYO/WIRE	TEMPORARY CARDIAC PACING WIRE
4	ARROW INTL., INC. 2 BERRY DR. MT. HOLLY, NJ 08060 US 610-378-0131 / 610-378-0131	TEMPORARY PACING CATHETER	VARIOUS STERILE TEMPORARY PACING CATHETERS
5	ARROW INTL., INC. 312 COMMERCE PL. ASHEBORO, NC 27203 US 610-378-0131 / 610-378-0131	TEMPORARY PACING CATHETER	VARIOUS STERILE TEMPORARY PACING CATHETERS
6	B BRAUN SURGICAL, SA CARRETERA DE TERRASSA 121 RUBI, 08191 SP 49-74-6195-1548 / 610-984-9074	STEELEX ELECTRODE SET	ELECTRODE
7	C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION 55 TECHNOLOGY DR. LOWELL, MA 01851 US 908-277-8000 / 908-277-8513	MULTIPLE	TEMPORARY PACING ELECTRODE CATHETERS
8	C.R. BARD, INC. 289 BAY RD. QUEENSBURY, NY 12804 US 908-277-8000 / 908-277-8513	MULTIPLE	TEMPORARY PACING ELECTRODE CATHETERS
9	COVIDIEN UK MANUFACTURING LTD, FORMERLY REGISTERED 154 FAREHAM ROAD GOSPORT, HAMPSHIRE, PO13 OAS UK 508-261-8587 / 203-492-5157	FLEXON TEMPORARY CARDIAC PACER LEAD	TEMPORARY CARDIAC PACER LEAD
10	CP MEDICAL 803 NE 25TH AVE. PORTLAND, OR 97232 US 770-271-0233 / 503-445-1635	CP PACING WIRE	PACING WIRE
11	EDWARDS LIFESCIENCES AG PARQUE INDUSTRIAL ITABO KM. 18.5 CARR. SANCHEZ HAINA, SAN CRISTOBAL, DR 949-250-2500 / 949-250-2698	ELECTRODE, PACEMAKER, TEMPORARY	ELECTRODE, PACEMAKER, TEMPORARY
12	EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY IRVINE, CA 92614 US 949-250-2500 / 949-250-2698	ELECTRODE, PACEMAKER, TEMPORARY	ELECTRODE, PACEMAKER, TEMPORARY
13	ESTECH, INC. 2603 CAMINO RAMON, STE 100 SAN RAMON, CA 94583 US 925-866-7111 / 925-866-7111	AFFIRM BIPOLAR PACING PROBE	PACING PROBE,TEMPORARY
14	ETHICON, INC. ROUTE 22 WEST SOMERVILLE, NJ 08876 US 908-218-2887 / 908-218-2996	STERILE TEMPORARY PACING WIRE	STERILE TEMPORARY PACING WIRE
15	ETHICON, LLC. RD. 183, KM. 8.3, INDUSTRIAL AREA HATO SAN LORENZO, PR 00754 US 908-218-2887 / 908-218-2996	STERILE TEMPORARY PACING WIRE	STERILE TEMPORARY PACING WIRE
16	HARMAC MEDICAL PRODUCTS, INC. 2201 BAILEY AVE. BUFFALO, NY 14211 US 716-897-4500 / 716-897-4500 189	MULTIPLE	VARIOUS STERILE TEMPORARY PACING CARDIAC CATHERTERS
17	MEDTRONIC CARDIAC SURGERY TECHNOLOGIES 7601 NORTHLAND DR. MINNEAPOLIS, MN 55428 US 763-514-4000 / 763-391-9030	DETECT SURGICAL PACKING AND MAPPING TOOL (10650)	SURGICAL PACKING AND MAPPING TOOL
18	MEDTRONIC FABRICATION S.A.S. 103 ROUTE D'ANOR FOURMIES, 59610 FR 763-514-4000 / 763-391-9030	MULTIPLE	VARIOUS MODELS OF TEMPORARY MYOCARDIAL PACING LEADS
19	MEDTRONIC HEART VALVES 8299 CENTRAL AVE., N.E. SPRING LAKE PARK, MN 55432 US 763-514-4000 / 763-391-9030	MULTIPLE	VARIOUS MODELS OF TEMPORARY MYOCARDIAL PACING LEADS
20	OSCOR CARIBE LLC ZONA FRANCA LAS AMERICAS NAVE I-2 SANTO DOMINGO, DR 727-937-2511 133 / 727-937-2511 133	VARIOUS	TEMPORARY PACING LEADS
21	OSCOR INC. 3816 DE SOTO BLVD. PALM HARBOR, FL 34683 US 727-937-2511 133 / 727-937-2511	TEMPORARY PACING PRODUCTS	VARIOUS MODELS OF STERILE TEMPORARY PACING PRODUCTS
22	ST. JUDE MEDICAL 14901 DEVEAU PL. MINNETONKA, MN 55345 US 651-483-2000 / 952-351-1544	PACEL, PACEMAKER, TEMPORARY, CATHETER	VARIOUS
23	TELEFLEX MEDICAL 4024 STIRRUP CREEK DR. SUITE 720 DURHAM, NC 27703 US 919-544-8000 / 919-433-4829	MULTIPLE TEMPORARY PACEMAKER ELECTRODES	VARIOUS TYPES OF TEMPORARY PACEMAKER ELECTRODES
24	TELEFLEX MEDICAL 2917 WECK DR. RESEARCH TRIANGLE PARK, NC 27709 US 919-544-8000 / 919-433-4829	MULTIPLE TEMPORARY PACEMAKER ELECTRODES	VARIOUS TYPES OF TEMPORARY PACEMAKER ELECTRODES
25	TELEFLEX MEDICAL 375 FORBES BLVD. MANSFIELD, MA 02048 US 919-544-8000 / 919-433-4829	MULTIPLE TEMPORARY PACEMAKER ELECTRODES	VARIOUS TYPES OF TEMPORARY PACEMAKER ELECTRODES
26	TELEFLEX MEDICAL PROLONGACION MISION EUSEBIO KINO # 1316,RANCHO EL DESCANSO TECATE, B.C., C.P.21478 MX 919-544-8000 / 919-433-4829	MULTIPLE TEMPORARY PACEMAKER ELECTRODES	VARIOUS TYPES OF TEMPORARY PACEMAKER ELECTRODES
27	UNITED MEDICAL INDUSTRIES CO. LTD. 3RD INDUSTRIAL CITY SANAYYA, OPPOSITE TO OBAIKAN RIYADH, CENTRAL PROVINCE, 11553 SA 009-661-2650665 / 009-661-2650665	PACEMAKER	TEMPORARY CARDIAC PACING WIRE
28	VASCOMED INSTITUT FUR KATHETERTECHNOLOGIE GMBH HERTZALLEE 1 BINZEN, D79589 GM 011-49-7621570900 / 727-942-1122	VASCOSTIM	TEMPORARY PACING LEAD
29	VASCOR MEDICAL CORP. 4634 TARAY LANE HOLIDAY, FL 34690 US 727-942-1122 / 727-942-1122		TEMPORARY HEARTWIRE