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 1986-06-26

PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY

Applicant Pacesetter Systems

K number K861422

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DXY 1986-06-17

MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN

Applicant Medtronic Vascular

K number K862071

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DXY 1986-06-17

MODIFY LABEL/SPECTRAX S & SX IMPLANT PULSE GENER

Applicant Medtronic Vascular

K number K862038

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DXY 1986-06-17

MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN

Applicant Medtronic Vascular

K number K862037

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DXY 1986-05-28

IMPLANT PROG PULSE GENERATOR, UNIPOLAR & BIPOLAR

Applicant Telectronics, Inc.

K number K860573

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DXY 1986-05-09

SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS

Applicant Cook Pacemaker Corp.

K number K861559

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DXY 1986-05-02

PROGRAMALITH III PULSE GENERATOR

Applicant Pacesetter Systems

K number K861140

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DXY 1986-04-23

BIPOLAR CARDIAC PACEMAKER, MODEL 110

Applicant Cardiac Control Systems, Inc.

K number K861009

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DXY 1986-03-31

UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762

Applicant Ela Medical, Inc.

K number K852973

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DXY 1986-03-17

MEDTRONIC MODELS 8316,8317,8318 PULSE GENERATORS

Applicant Medtronic Vascular

K number K855147

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DXY 1986-03-07

PHOENIX MODELS 250/251 PULSE GENERATORS

Applicant Pacesetter Systems

K number K855081

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DXY 1986-02-28

ALTERNATE STERILE PKG IMPLANTABLE PULSE GENERATORS

Applicant Medtronic Vascular

K number K854482

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DXY 1986-02-24

MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN.

Applicant Cook Pacemaker Corp.

K number K860466

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DXY 1986-02-24

MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER.

Applicant Cook Pacemaker Corp.

K number K860202

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DXY 1986-02-24

CCS IMPLANTABLE MAESTRO 106/206/210 CARDIAC PACEMA

Applicant Cardiac Control Systems, Inc.

K number K853471

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DXY 1986-02-24

CCS IMPLANTABLE MAESTRO SERIES 200 CARDIAC PACEMAK

Applicant Cardiac Control Systems, Inc.

K number K853400

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DXY 1986-01-22

TELEMETRY WAND MODEL

Applicant Cardiac Pacemakers, Inc.

K number K855171

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DXY 1986-01-16

IMPLANTABLE PROGRAMMABLE PULSE GENERATOR

Applicant Telectronics, Inc.

K number K854560

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DXY 1986-01-14

ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER

Applicant Sorin Biomedica, Fiat, USA, Inc.

K number K852641

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DXY 1986-01-14

CORDIS MULTICOR ST, MODEL 350A

Applicant Cordis Corp.

K number K851968

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DXY 1986-01-07

PROGRAMALITH III MODELS 238 & 239

Applicant Pacesetter Systems

K number K854195

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DXY 1985-12-19

BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY

Applicant Cook Pacemaker Corp.

K number K854919

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DXY 1985-12-03

MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE

Applicant Cordis Corp.

K number K854214

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DXY 1985-12-03

COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS

Applicant Cook Pacemaker Corp.

K number K854132

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DXY 1985-12-03

SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM

Applicant Sorin Biomedica, Fiat, USA, Inc.

K number K851365

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DXY 1985-11-08

SUPRIMA MODEL 254-24

Applicant Intermedics, Inc.

K number K852340

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DXY 1985-11-08

SUPRIMA MODEL 254-22

Applicant Intermedics, Inc.

K number K852339

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DXY 1985-11-01

BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS

Applicant Telectronics, Inc.

K number K854143

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DXY 1985-11-01

CORDIS MODELS 336A,336B,337A & 334 CARDIAC PACEMAK

Applicant Cordis Corp.

K number K852748

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DXY 1985-11-01

MEDTRONICS MODELS 8320/8322/8329

Applicant Medtronic Vascular

K number K852688

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DXY 1985-10-23

COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER

Applicant Cook Pacemaker Corp.

K number K853651

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DXY 1985-10-23

COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI

Applicant Cook Pacemaker Corp.

K number K853590

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DXY 1985-09-13

NEOS - M ABP

Applicant Biotronik Sales, Inc.

K number K853058

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DXY 1985-09-12

IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW

Applicant Telectronics, Inc.

K number K853206

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DXY 1985-09-12

TRIOS - M

Applicant Biotronik Sales, Inc.

K number K853057

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DXY 1985-08-19

CARIO-PACE DURAPULSE P101 COATED PULSE GENERATOR

Applicant Cardio-Pace Medical, Inc.

K number K853425

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DXY 1985-08-06

CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA

Applicant Cardiac Control Systems, Inc.

K number K852435

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DXY 1985-07-25

#335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ

Applicant Intermedics, Inc.

K number K853034

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DXY 1985-07-25

ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251

Applicant Ela Medical, Inc.

K number K853017

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DXY 1985-07-19

SUPRIMA II MODEL 254-26

Applicant Intermedics, Inc.

K number K852431

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DXY 1985-07-17

SUPRIMA II MODEL 254-28

Applicant Intermedics, Inc.

K number K852432

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DXY 1985-07-17

SUPRIMA II MODEL 253-23

Applicant Intermedics, Inc.

K number K852430

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DXY 1985-06-21

MULTICOR S, MODELS 330A/331A

Applicant Cordis Corp.

K number K851420

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DXY 1985-06-18

CORDIS MULTICOR S 330A & 331A CARDIAC PACEMAKERS

Applicant Cordis Corp.

K number K844360

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DXY 1985-06-11

MULTICOR GAMMA 402 SERIES PACER

Applicant Cordis Corp.

K number K851419

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DXY 1985-06-11

OMNI-ATRICOR MODEL 308A

Applicant Cordis Corp.

K number K851418

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DXY 1985-06-11

MULTICOR GAMMA MODELS 336/337

Applicant Cordis Corp.

K number K851417

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DXY 1985-06-11

STANICOR GAMMA 333B/334A

Applicant Cordis Corp.

K number K851416

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DXY 1985-05-16

PROGRAMALITH III MODEL 249 PULSE GENERATOR

Applicant Pacesetter Systems

K number K851861

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DXY 1985-05-16

COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GE

Applicant Cook Pacemaker Corp.

K number K851699

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DXY 1985-05-15

PROGRAMALITH III 240 PULSE GENERATOR

Applicant Pacesetter Systems

K number K850464

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DXY 1985-04-18

NEOS-LP PULSE GENERATOR

Applicant Biotronik Sales, Inc.

K number K844842

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DXY 1985-04-18

KALOS-04 PULSE GENERATOR

Applicant Biotronik Sales, Inc.

K number K844841

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DXY 1985-04-18

NEOS - PULSE GENERATOR

Applicant Biotronik Sales, Inc.

K number K844812

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DXY 1985-04-18

NEOS-M PULSE GENERATOR

Applicant Biotronik Sales, Inc.

K number K844795

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DXY 1985-04-18

LEPTOS PULSE GENERATOR

Applicant Biotronik Sales, Inc.

K number K844794

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DXY 1985-04-04

IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II

Applicant Telectronics, Inc.

K number K851081

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DXY 1985-04-04

QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR

Applicant Telectronics, Inc.

K number K850252

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DXY 1985-04-01

PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR

Applicant Pacesetter Systems

K number K850651

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DXY 1985-03-21

CCS IMPLANTABLE MAESTRO SERIES 100-HEART PACEMAKER

Applicant Cardiac Control Systems, Inc.

K number K850384

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DXY 1985-03-01

COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM

Applicant Cook Pacemaker Corp.

K number K850656

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DXY 1985-03-01

EKG TRANSMITTER MODEL 5134

Applicant Instromedix, Inc.

K number K842051

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DXY 1985-02-08

MEDTRONIC MODELS 8432/8433/8434 - PACEMAKER PULSE

Applicant Medtronic Vascular

K number K844958

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DXY 1985-02-08

MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR

Applicant Medtronic Vascular

K number K844957

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DXY 1985-02-08

SUPRIMA 253-21 IMPLANTABLE PULSE GENERATOR

Applicant Intermedics, Inc.

K number K844793

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DXY 1985-01-10

VIVALITH II 301 PULSE GENERATOR

Applicant Pacesetter Systems

K number K844334

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DXY 1985-01-10

MULTILITH PULSE GENERATORS, 1141 & 2141

Applicant Ela Medical, Inc.

K number K842193

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DXY 1984-12-03

PULSE GENERATOR 696, 696B & 696L

Applicant Siemens Elema AB

K number K841232

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DXY 1984-12-03

PULSE GENERATOR 686, 686B 686L

Applicant Siemens Elema AB

K number K841230

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DXY 1984-12-03

PULSE GENERATOR 689, 689B & 689L

Applicant Siemens Elema AB

K number K841225

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DXY 1984-11-29

MULTILITH 2 PULSE GENERATOR 1141 & 2141

Applicant Ela Medical, Inc.

K number K842220

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DXY 1984-10-26

IMPLANTABLE PROGRAMMABLE PULSE GENERAT

Applicant Telectronics, Inc.

K number K842473

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DXY 1984-10-17

MEDTRONIC 5984-5984LP-5985

Applicant Medtronic Vascular

K number K843837

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DXY 1984-10-17

ASTRA 2, ASTRA 3, 4 & 6

Applicant Cardiac Pacemakers, Inc.

K number K842394

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DXY 1984-08-29

MEDTRONIC 8437/8438

Applicant Medtronic Vascular

K number K843089

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DXY 1984-08-06

NEOS LP

Applicant Biotronik Sales, Inc.

K number K841633

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DXY 1984-08-03

LEPTOS

Applicant Biotronik Sales, Inc.

K number K841635

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DXY 1984-08-03

LITHIUM PACEMAKER 811-811L & 811XL

Applicant Omikron Scientific, Ltd.

K number K840748

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DXY 1984-07-11

COOK PACEMAKER 216 BIPOLAR CARDIAC -

Applicant Cook Pacemaker Corp.

K number K841983

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DXY 1984-07-11

COOK PACEMAKER 215 UNIPOLAR CARDIAC-

Applicant Cook Pacemaker Corp.

K number K841928

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DXY 1984-07-06

COOK PACEMAKER CORP. 115 UNIPOLAR CARDI

Applicant Cook Pacemaker Corp.

K number K842081

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DXY 1984-07-06

PULSE GENERATOR 678L

Applicant Siemens Elema AB

K number K841233

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DXY 1984-06-26

PULSE GENERATOR 688B & 688L

Applicant Siemens Elema AB

K number K841231

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DXY 1984-06-26

PULSE GENERATOR 718B & 718L

Applicant Siemens Elema AB

K number K841228

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DXY 1984-06-26

PULSE GENERATOR 728, 728B & 728L

Applicant Siemens Elema AB

K number K841226

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DXY 1984-06-25

PULSE GENERATOR KALOS-04

Applicant Biotronik Sales, Inc.

K number K841950

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DXY 1984-06-25

NEOS M

Applicant Biotronik Sales, Inc.

K number K841636

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DXY 1984-06-25

PULSE GENERATOR 698, 698B & 698L

Applicant Siemens Elema AB

K number K841229

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DXY 1984-05-30

PRIMA 236-02 NONPROGRAMMABLE CARDIAC

Applicant Intermedics, Inc.

K number K841404

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DXY 1984-05-16

CARCIAC PULSE GENERATOR 254-20

Applicant Intermedics, Inc.

K number K841075

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DXY 1984-05-16

CARDIAC PULSE GENERATOR 254-18

Applicant Intermedics, Inc.

K number K841074

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DXY 1984-05-16

QUANTUM, UNIPOLAR, MULTI-PROGRAMMABLE

Applicant Intermedics, Inc.

K number K841073

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DXY 1984-05-16

IMPLANTABLE PROGRAMMABLE PULSE GENER

Applicant Telectronics, Inc.

K number K840737

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DXY 1984-05-02

PACEMAKER 147 VVI-THE OPTINIA

Applicant Telectronics, Inc.

K number K840701

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DXY 1984-02-10

IMPLANTABLE UNIPOLAR CARDIAC PULSE GEN

Applicant Telectronics, Inc.

K number K833428

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DXY 1984-02-10

IMPLANTABLE BIPOLAR CARDIAC PULSE GEN

Applicant Telectronics, Inc.

K number K833427

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DXY 1984-01-30

PULSE GENERATOR MODEL 688

Applicant Burditt & Calkins-Siemens-Elema

K number K833519

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DXY 1983-12-16

IMPLANTABLE PULSE GENERATOR

Applicant Intermedics, Inc.

K number K834096

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DXY 1983-12-01

OPTIMA MDT PULSE GENERATOR W/TELEMETRY

Applicant Telectronics, Inc.

K number K833798

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DXY 1983-11-14

PRIMA-UNIPOLAR CARDIAC PULSE GENERAT

Applicant Intermedics, Inc.

K number K832914

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