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
1980-09-18
DXY
1980-09-16
SIEMENS-ELEMA PULSE GENERATOR 625
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DXY
1980-09-09
BATTERY FOR #229-01 PULSE GENERATOR
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DXY
1980-09-09
INSULATING SHEATH
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DXY
1980-09-09
EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE
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DXY
1980-09-09
MEDTRONIC MODEL 2409
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DXY
1980-08-27
VIVALITH 5, - MDL-201A & TDL-201A
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DXY
1980-08-20
SONACOLOR 6100
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DXY
1980-08-14
INTERMEDICS THIN LITH IV SERIES UNIPOLAR
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DXY
1980-07-08
MULTICOR (GAMMA) MODEL 336 & MODEL 337
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DXY
1980-06-30
UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN.
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DXY
1980-06-30
MICROTHIN-D1 (MOD. 0620)
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DXY
1980-06-30
MICROTHIN-P1 (MOD. 0622)
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DXY
1980-06-30
PROGRAMMABLE BIPOLAR CARDIAC GENERATOR
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DXY
1980-06-26
MEDTRONIC MODELS 5966/5967, ETC.
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DXY
1980-06-04
ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN.
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DXY
1980-05-20
MODEL 5985 PACEMAKER PULSE GENERATOR
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DXY
1980-05-02
PULSE GENERATORS MODELS 657 & 677
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DXY
1980-04-24
MODEL 253-11 CYBERLITH PULSE GENERATOR
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DXY
1980-04-16
CYBERLITH IMPLANTABLE PULSE GEN. #253-02
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DXY
1980-04-16
NOMOS-01 PULSE GENERATOR
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DXY
1980-04-08
CYBERLITH IMPLANTABLE PULSE GEN. #253-04
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DXY
1980-03-25
IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC
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DXY
1980-03-17
ARCOLITH 3021-CARDIAC PULSE GENERATOR
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DXY
1980-02-11
OVALITH P-BP BIPOLAR CARDIAC PACEMAKER
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DXY
1980-02-05
SORIN PULSE GENERATOR MODEL # LIT 214 H
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DXY
1980-02-05
PULSE GENERATOR, MODEL NO. LIT 222
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DXY
1980-01-31
MICROTHIN-PI
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DXY
1980-01-31
MICROTHIN-DI
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DXY
1980-01-11
IMPLANTABLE BIPOLAR CARDIAC PULSE GEN.
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DXY
1979-12-20
IMPLANTABLE PROGRAMMABLE UNIPOLAR
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DXY
1979-11-29
ARCOLITH 3020-CARDIAC PULSE GENERATOR
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DXY
1979-11-29
ARCOLITH 2100-CARDIAC PULSE GENERATOR
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DXY
1979-11-29
CARDIAC PACEMAKER P4000 SER. & P1000
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DXY
1979-11-27
UNIFOCAL 3-2 MODELS UNIPOLAR & BIPOLAR
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DXY
1979-11-27
UNIFOCAL 2-UNIPOLAR & BIPOLAR
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DXY
1979-11-27
UNIFOCAL 1 UNIPOLAR DEMAND R WAVE
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DXY
1979-11-15
MEDTRONIC MODELS 5984/5985
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DXY
1979-10-26
CARDIAC PACEMAKER C4000, C1000 SER.
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DXY
1979-10-22
IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD
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DXY
1979-10-22
OMNI-STANICOR (THETA) MOD 237A
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DXY
1979-10-12
PULSE GENERATOR MODEL 637
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DXY
1979-09-28
CORDIS BIPOLAR PACER CONNECTOR SYSTEM
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DXY
1979-09-28
PULSE GENERATORS, MODELS 5983, 5989
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DXY
1979-09-27
IMPLANTABLE VENTRICULAR-INHIBITED
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DXY
1979-09-27
ARCOLITH 2000
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DXY
1979-09-26
EDWARDS PACEMAKER 30 UNIPOLAR GENERATOR
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DXY
1979-09-20
PROGRAMMER, MEDTRONIC MODEL 5984/5985
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DXY
1979-09-20
MODEL 221 PROGRAMALITH PULSE GENERATOR
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DXY
1979-09-19
IMPLANTABLE PULSE GENERATOR PACEMAKERS
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DXY
1979-09-12
MODEL 228-02 THINLITH II PACEMAKER, BIPO
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DXY
1979-09-07
LITHICRON II 0403 IMPLANTABLE PACEMAKER
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DXY
1979-09-04
IMPLANTABLE PULSE GENERATOR PACEMAKER
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DXY
1979-08-10
BJORK-SHILEY AORTIC GRAFT VALVE PROSTH
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DXY
1979-08-10
LITHICRON MODEL 0401, PACEMAKER
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DXY
1979-08-10
MDL-201A & T DL-201A PULSE GENERATOR
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DXY
1979-08-10
PULSE GENERATOR, R WAVE DEMAND
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DXY
1979-08-03
ARCO PROGAMMABLE PACEMAKER SYSTEM
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DXY
1979-07-30
UNILITH PULSE GENERATOR
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DXY
1979-07-30
OVALITH-300
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DXY
1979-07-24
BATTERY CHARGER, 171 PACEMAKER
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DXY
1979-07-24
PULSE GENERATOR, MODEL 171
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DXY
1979-07-10
ARCOLITH 4000
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DXY
1979-06-27
PULSE GENERATOR MODEL 629
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DXY
1979-06-20
MODELS 2411/2418 VENTRICULAR-INHIBITED
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DXY
1979-06-01
VITALITH S 3000 SERIES
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DXY
1979-05-31
CARDIAC PULSE GENERATOR, 16 SERIES
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DXY
1979-05-25
GENERATOR, 16 SERIES, MODIFIED TOP CAP
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DXY
1979-05-16
OMNI-STANICOR-(THETA) MODEL 217
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DXY
1979-05-08
PULSE GENERATOR MODEL 61 AND 128
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DXY
1979-05-08
28 UNIPOLAR AND BIPOLAR PULSE GENERATORS
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DXY
1979-04-26
PACEMAKERS WITHOUT SILASTIC COATING
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DXY
1979-03-21
CARDIOPHONE
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DXY
1979-03-20
MICROLITH MODELS 505;605;507;607;703;803
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DXY
1979-03-19
PACEMAKER, OVALITH-D CARDIAC
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DXY
1979-02-26
MINILITH AND MICROLITH
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DXY
1979-02-08
BIPOLAR, STANICOR LAMBDA MODEL 236,235
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DXY
1979-02-08
PULSE GENERATOR, IMPLANTABLE CARDIAC
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DXY
1979-01-24
ISOLATION SLEEVE, MODEL 346-01
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DXY
1979-01-24
ISOLATION SLEEVE, MODEL 348-01
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DXY
1979-01-24
ISOLATION SLEEVE, MODEL 347-01
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DXY
1979-01-24
ISOLATION SLEEVE, MODEL 349-01
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DXY
1978-12-27
PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT
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DXY
1978-12-22
MICROLITH A MODEL 803
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DXY
1978-12-22
MICROLITH A MODEL 703
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DXY
1978-12-22
LITHICRON F PROGRAMMABLE PULSE GEN
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DXY
1978-12-21
PULSTRON MODEL 100
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DXY
1978-12-07
PACEMAKER, MODEL 229-01
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DXY
1978-12-06
GENERATOR, PULSE, SORIN MODEL DL-1
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DXY
1978-12-04
OVALITH 10BP
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DXY
1978-10-03
GENERATOR, PULSE, MODEL 5997
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DXY
1978-10-03
GENERATORS, PULSE, MODELS 5988/5989
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DXY
1978-10-03
ARCOBIOLITH PACEMAKER MODEL
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DXY
1978-09-27
GENERATORS: UDL-201B, BDL-201B, MDL-201B
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DXY
1978-09-27
GENERATOR, PULSE, MODEL 160B
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DXY
1978-09-27
PACEMAKER, MODEL 225 & 227
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DXY
1978-09-07
CARDIAL PULSE GENERATORS
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DXY
1978-09-07
PULSE GENERATOR MODEL 208
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DXY
1978-09-07
GENERATOR, CARDIAC PULSE, 250B
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DXY
1978-08-31
GENERATOR, PULSE, PACEMAKER
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