Implantable Pacemaker Pulse-Generator

FDA product code DXY · 461 cleared devices

Class 3 Cardiovascular

Regulation: 21 CFR 870.3610
Review panel: CV
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-11-11 – 1999-11-10

DXY 1983-10-28

SILICONE RUBBER ISOLATION SLEEVE 350-01

Applicant Intermedics, Inc.

K number K833199

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DXY 1983-10-27

SILICONE RUBBER ISOLATION SLEEVE 351-01

Applicant Intermedics, Inc.

K number K833198

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DXY 1983-10-27

GENERATOR, PULSE, PACEMAKER #532

Applicant Vitatron Medical BV

K number K831860

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DXY 1983-10-27

PACEMAKER PROGRAMMER #2032

Applicant Vitatron Medical BV

K number K831859

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DXY 1983-10-12

QUANTUM BIPOLAR CARDIAC PULSE GENERATOR

Applicant Intermedics, Inc.

K number K831633

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DXY 1983-10-04

MODEL 329T PROGRAMMABLE, BIPOLAR CARDI

Applicant Cook Pacemaker Corp.

K number K832893

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DXY 1983-08-16

IMPLANTABLE PROGRAM. CARDIAC PULSE GEN

Applicant Telectronics, Inc.

K number K831771

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DXY 1983-08-08

MODEL 327T UNIPOLAR CARDIAC PULSE GEN

Applicant Cook Pacemaker Corp.

K number K832052

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DXY 1983-07-12

COMMAND ULTRA II

Applicant Cardiac Pacemakers, Inc.

K number K831216

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DXY 1983-06-15

COMMAND ULTRA I

Applicant Cardiac Pacemakers, Inc.

K number K831161

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DXY 1983-05-27

SIEMENS-ELMA PULSE GENERATOR #718

Applicant Burditt & Calkins-Siemens-Elema

K number K830344

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DXY 1983-05-25

NEDS-01 & EPR-500

Applicant Biotronik Sales, Inc.

K number K830862

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DXY 1983-03-24

IMPLANTABLE BIPOLAR CARDIAC PULSE GEN

Applicant Telectronics, Inc.

K number K830390

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DXY 1983-03-24

IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 242

Applicant Pacesetter Systems

K number K823878

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DXY 1983-03-17

UNILITH PULSE GENERATOR VVI #7542

Applicant Ela Medical, Inc.

K number K830401

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DXY 1983-03-17

COMMAND ULTRA II

Applicant Cardiac Pacemakers, Inc.

K number K830382

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DXY 1983-03-16

MEDTRONIC MODELS 59401 5941

Applicant Medtronic Vascular

K number K823831

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DXY 1983-03-10

CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC

Applicant Intermedics, Inc.

K number K823863

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DXY 1983-02-18

AFP PULSE GENERATOR

Applicant Pacesetter Systems

K number K823559

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DXY 1983-02-18

AFP SYSTEM PULSE GENERATOR MODEL 261/262

Applicant Pacesetter Systems

K number K822639

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DXY 1982-12-22

TELEMETRY DECODER #540-02

Applicant Intermedics, Inc.

K number K823678

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DXY 1982-12-22

DURAPULSE

Applicant Cpm International, Inc.

K number K823371

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DXY 1982-12-15

CORATOMIC #VX5-105 & VX5-205 PULSE GEN.

Applicant Coratomic, Inc.

K number K822791

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DXY 1982-11-01

KALOS-03 BIPOLAR

Applicant Biotronik Sales, Inc.

K number K822907

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DXY 1982-10-15

MODEL 325D UNIPOLAR CARDIAC PULSE GEN

Applicant Cook Pacemaker Corp.

K number K822904

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DXY 1982-10-04

JAIN INSULATING BOOT MODEL 225B

Applicant Cook Pacemaker Corp.

K number K822652

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DXY 1982-10-04

COMMAND NP

Applicant Cardiac Pacemakers, Inc.

K number K822309

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DXY 1982-10-04

ENERTRAX MODEL 7100E

Applicant Medtronic Vascular

K number K822297

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DXY 1982-08-06

MEDTRONIC ENERTRAX MODEL 7100

Applicant Medtronic Vascular

K number K822147

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DXY 1982-06-22

C-101-P

Applicant Coratomic, Inc.

K number K820939

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DXY 1982-05-28

CORATOMIC MODEL OVALITH-920

Applicant Coratomic, Inc.

K number K821033

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DXY 1982-05-28

CORATOMIC MODEL OVALITH 920BP

Applicant Coratomic, Inc.

K number K821014

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DXY 1982-05-07

COOK #326T PROGRAM/TELEMETRY BIPOLAR

Applicant Cook Pacemaker Corp.

K number K821147

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DXY 1982-05-07

PULSE GENERATOR

Applicant Biotronik Sales, Inc.

K number K821073

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DXY 1982-05-07

PROGRAMMALITH II, #225 & 226

Applicant Pacesetter Systems

K number K821003

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DXY 1982-04-15

PULSE GENERATOR 678 B

Applicant Siemens Elema AB

K number K820657

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DXY 1982-04-09

QUANTUM MODELS 253-09, 254-09 254-10

Applicant Intermedics, Inc.

K number K820853

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DXY 1982-04-09

IMPLANTABLE, MULTIPROGRAMMABLE

Applicant Biotronik Sales, Inc.

K number K820774

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DXY 1982-03-18

MULTICOR (GAMMA) 402 CARDIAC PACER

Applicant Cordis Corp.

K number K820356

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DXY 1982-03-15

COMMAND ULTRA I

Applicant Cardiac Pacemakers, Inc.

K number K820231

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DXY 1982-02-12

MEDICAL MULTILITH PULSE GENERA-1140

Applicant Ela Medical, Inc.

K number K813246

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DXY 1982-01-22

SIEMENS-ELEMA PULSE GENERATOR 659

Applicant Siemens Elema AB

K number K813576

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DXY 1982-01-22

COMMAND P5

Applicant Cardiac Pacemakers, Inc.

K number K813534

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DXY 1981-12-10

BIPOLAR OPTIMA MP #255

Applicant Telectronics, Inc.

K number K813079

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DXY 1981-12-10

SIEMENS-ELEMA PULSE GENERATOR 668 B

Applicant Siemens Corp.

K number K812610

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DXY 1981-12-02

DIRECTIONAL BOOT

Applicant Pacesetter Systems

K number K813150

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DXY 1981-11-27

CARDIOBEEPER MEMORY MONITOR

Applicant Survival Technology, Inc.

K number K813101

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DXY 1981-11-16

SYNTHEMED PULSE GENERATOR VVI MODEL 1000

Applicant Synthemed Corp.

K number K812464

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DXY 1981-11-05

MODEL 325C UNIPOLAR CARDIAC PULSE GEN.

Applicant Cook Pacemaker Corp.

K number K812832

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DXY 1981-10-29

IMPLANTABLE VENTRICULAR-INHIBITED CARDI

Applicant Telectronics, Inc.

K number K812790

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DXY 1981-10-29

MODEL 325T PROGRAMMABLE PULSE GENERATOR

Applicant Cook Pacemaker Corp.

K number K812358

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DXY 1981-10-13

KALOS-03

Applicant Biotronik Sales, Inc.

K number K812218

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DXY 1981-09-23

MEDTRONIC MODEL 2409

Applicant Medtronic Vascular

K number K812580

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DXY 1981-09-23

TELEMETRY DECODER

Applicant Intermedics, Inc.

K number K801339

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DXY 1981-09-23

CYBERLITH IX IMPLANTABLE PULSE GENERATOR

Applicant Intermedics, Inc.

K number K801337

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DXY 1981-09-16

MEDTRONIC ENERTRAX MODEL 7100

Applicant Medtronic Vascular

K number K812096

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DXY 1981-08-31

MEDTRONIC SPECTRAX

Applicant Medtronic Vascular

K number K812153

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DXY 1981-07-27

COMMAND P5(BIPOLAR PULSE GENERATOR)

Applicant Cardiac Pacemakers, Inc.

K number K811402

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DXY 1981-07-20

CORATOMIC MODEL OVALITH-920BP

Applicant Corptomic

K number K811768

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DXY 1981-07-20

CORDIS OMNI-ARTICOR CARDIAC PACER #308

Applicant Cordis Corp.

K number K811691

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DXY 1981-07-20

ELA MEDICAL UNILITH 7540 PULSE GENERATOR

Applicant Ela Medical, Inc.

K number K810887

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DXY 1981-07-01

UNIPOLAR SPECTRAX IMPL. PULSE GENERAT.

Applicant Medtronic Vascular

K number K811350

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DXY 1981-06-16

#326 PROGRAMMABLE CARD. PULSE GENERATOR

Applicant Cook Pacemaker Corp.

K number K810885

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DXY 1981-06-16

#325 PROGRAMMABLE CARD. PULSE GENERATOR

Applicant Cook Pacemaker Corp.

K number K810884

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DXY 1981-05-29

MULTILITH PULSE GENERATOR #1140

Applicant Ela Medical, Inc.

K number K810489

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DXY 1981-05-29

ELA MEDICAL UNILITH PULSE GENERATOR

Applicant Ela Medical, Inc.

K number K810142

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DXY 1981-05-27

INTERMEDICS CYBERLITH BIPOLAR CARDIAC

Applicant Intermedics, Inc.

K number K811221

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DXY 1981-05-27

MEDTRONIC PULSE GENERATOR

Applicant Medtronic Vascular

K number K811123

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DXY 1981-05-27

MODELS 5976/5977 PACEMAKER PULSE GENER

Applicant Medtronic, Inc.

K number K810677

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DXY 1981-05-15

CORATOMIC MODEL OVALITH-920

Applicant Coratomic, Inc.

K number K810808

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DXY 1981-05-15

MODELS 8420 THRU 8423 PACEMAKER GENER

Applicant Medtronic Vascular

K number K810734

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DXY 1981-05-01

MODEL 230-06 CYBERLITH TM I BIPOLAR IN

Applicant Intermedics, Inc.

K number K811066

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DXY 1981-05-01

MODEL 230-05 CYBERLITH I BIPOL. PULSE G.

Applicant Intermedics, Inc.

K number K810800

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DXY 1981-05-01

THINLITH III UNIPOLAR CARDIAC PULSE GEN.

Applicant Intermedics, Inc.

K number K810752

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DXY 1981-04-14

INSULATIVE COATING FOR CARD. PULSE GEN

Applicant Intermedics, Inc.

K number K810901

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DXY 1981-04-14

IMPLANTABLE PROGRAMMABLE CARDIAC PULSE

Applicant Telectronics, Inc.

K number K810603

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DXY 1981-04-01

CYBERLITH I PULSE GENERATOR MODEL 253-04

Applicant Intermedics, Inc.

K number K810385

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DXY 1981-04-01

INTERMEDICS CYBERLITH I BIOPOLAR CARDI

Applicant Intermedics, Inc.

K number K810383

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DXY 1981-03-13

THINLITH II PULSE GNEERATOR MODEL 227-05

Applicant Intermedics, Inc.

K number K810386

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DXY 1981-03-05

STERILE PACKAGING

Applicant Telectronics, Inc.

K number K810410

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DXY 1981-02-23

UNIFOCAL 3

Applicant American Pacemaker Corp.

K number K810121

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DXY 1981-02-12

MULTI-PROGRAMMABLE PACEMAKER & PROGRMR.

Applicant Medtronic Vascular

K number K801584

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DXY 1981-02-05

SIEMENS-ELEMA PULSE GENERATOR 678

Applicant Siemens Elema AB

K number K802864

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DXY 1981-01-29

SIEMENS-ELEMA MYOCARDIAL LEAD

Applicant Siemens Elema AB

K number K810036

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DXY 1981-01-22

IMPL. PROGRAMMABLE BIPOLAR CARD.GEN.#274

Applicant Telectronics, Inc.

K number K803197

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DXY 1981-01-07

CYBERLITH PROGRAMMER

Applicant Intermedics, Inc.

K number K801338

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DXY 1980-12-22

MICROTHIN-PII BIPOLAR PULSE GEN. #0621

Applicant Cardiac Pacemakers, Inc.

K number K803035

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DXY 1980-12-22

MICROTHIN-PII BIPOLAR PULSE GEN. #0623

Applicant Cardiac Pacemakers, Inc.

K number K803034

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DXY 1980-12-22

MICRO THIN-PII, #0523

Applicant Cardiac Pacemakers, Inc.

K number K802353

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DXY 1980-12-22

MICRO THIN-DII, #0521

Applicant Cardiac Pacemakers, Inc.

K number K802352

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DXY 1980-12-16

UNIFOCAL VP, MODELS 7501 AND 7502

Applicant American Pacemaker Corp.

K number K800746

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DXY 1980-12-01

SIEMENS-ELEMA PULSE GENERATOR 668

Applicant Siemens Elema AB

K number K801324

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DXY 1980-11-19

MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN.

Applicant Arco Medical Products Co.

K number K802588

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DXY 1980-11-19

LITHICRON 0520 P-SYNCHRONEOUS PULSE GEN.

Applicant Medcor, Inc.

K number K792609

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DXY 1980-10-31

MICROTHIN-PI BIPOLAR PULSE GENERATOR

Applicant Cardiac Pacemakers, Inc.

K number K802410

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DXY 1980-10-31

MICROTHIN-DI BIPOLAR PULSE GENERATOR

Applicant Cardiac Pacemakers, Inc.

K number K802409

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DXY 1980-10-03

SORIN PULSE GENERATOR, MODEL #LIT-214

Applicant Bentley Laboratories, Inc.

K number K801640

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DXY 1980-09-26

IMPLANTABLE VENTRICULAR-INHIB. C.P. GEN

Applicant Telectronics, Inc.

K number K802028

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DXY 1980-09-26

PROGRAMALITH #'S 221, 222, 221A & 222A

Applicant Pacesetter Systems

K number K801978

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DXY 1980-09-26

BIFOCAL 2 8200 SERIES (A,B C,D)

Applicant American Pacemaker Corp.

K number K800379

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