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
1999-11-10
DXY
1997-08-29
OPUS S MODEL 4121 AND 4124 PACEMAKERS
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DXY
1996-03-04
PIKOS LP 01, PIKOS LP E01
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DXY
1995-12-15
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
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DXY
1995-12-15
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
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DXY
1995-09-29
MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
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DXY
1995-09-29
NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
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DXY
1995-09-01
OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)
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DXY
1995-07-12
PELLETHANE 75D
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DXY
1995-05-15
TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES
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DXY
1995-05-15
CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER
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DXY
1995-05-03
CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER
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DXY
1994-08-30
PIKOS E 01-B
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DXY
1994-05-02
MINIX/MINIX ST PULSE GENERATORS
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DXY
1993-08-19
PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER
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DXY
1993-05-14
MEDTRONIC MINIX & MINIX ST PULSE GENERATORS
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DXY
1993-05-14
CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER
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DXY
1992-10-28
ASTRA T2, ASTRA T4, ASTRA T6
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DXY
1992-03-17
INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG
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DXY
1992-03-16
SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER
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DXY
1992-02-26
PIKOS 01 & PIKOS E 01
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DXY
1991-10-16
MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER
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DXY
1991-08-22
MODEL 4220
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DXY
1991-07-26
MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE
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DXY
1991-05-16
8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS
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DXY
1991-05-16
MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE
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DXY
1991-05-07
TRIOS 02
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DXY
1991-01-18
OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE
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DXY
1991-01-03
MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE
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DXY
1991-01-03
MEDTRONIC MODEL 5301B TEST CABLE
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DXY
1990-12-20
VACUUM BAKE CYCLE
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DXY
1990-10-23
IMPLANTABLE PULSE DEVICES
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DXY
1990-09-14
NEOS (TM) 02 B PULSE GENERATOR
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DXY
1990-07-03
MINIX, MINIX ST, NEW IC: L74
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DXY
1990-07-03
MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE.
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DXY
1990-04-26
MODIFIED MODEL 5401B TEST CABLE
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DXY
1990-03-14
OPUS MODEL 4021, VVI, 5MM UNIPOLAR
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DXY
1990-03-14
OPTIMA MPT MODEL 5281E AND MODEL 5282E
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DXY
1990-01-26
MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR
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DXY
1990-01-18
KALOS 05 PULSE GENERATOR
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DXY
1989-11-01
NANOS
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DXY
1989-10-26
NEOS 02
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DXY
1989-10-17
LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD
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DXY
1989-09-26
ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS
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DXY
1989-09-26
OPUS MODEL 4001
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DXY
1989-09-20
OPUS MODELS 4033 AND 4034
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DXY
1989-09-12
OPTIMA MPT AND SPT PACEMAKERS
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DXY
1989-08-25
MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS
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DXY
1989-08-25
HOME BLOOD PRESSURE KIT, ANEROID
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DXY
1989-08-17
OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR
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DXY
1989-03-28
VS-1 MODEL NUMBER 251K PULSE GENERATOR
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DXY
1989-03-10
ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE
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DXY
1989-02-10
AFP MODEL 262T PULSE GENERATOR
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DXY
1989-01-26
OPTIMA MPT AND SPT PACEMAKERS
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DXY
1989-01-25
UNILITH 3 MODELS 7580/7583/7680/7683
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DXY
1989-01-13
VENTRALITH I
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DXY
1988-11-17
MINIX 8340, 8341, 8342 MINIX-ST 8330, 8331
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DXY
1988-11-17
MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS
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DXY
1988-11-14
OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024
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DXY
1988-10-17
MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER
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DXY
1988-09-23
CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066
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DXY
1988-09-14
PROLOG MP 658M PULSE GENERATOR
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DXY
1988-09-12
OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004
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DXY
1988-09-12
OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004
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DXY
1988-07-22
CHANGE TO CATHODE POWDER SPECIFICATION
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DXY
1988-07-18
OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D
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DXY
1988-05-26
VICOR MODELS 410B & 410D AND MODIFIED 410A PACEMA.
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DXY
1988-05-06
MULTICOR AND PACEMAKERS
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DXY
1988-04-11
MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS
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DXY
1988-03-31
MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER
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DXY
1988-02-22
VICOR PACER, MODEL 410A
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DXY
1988-01-07
MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERS
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DXY
1987-12-29
CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK.
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DXY
1987-11-23
QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.
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DXY
1987-11-04
PROLOG MP PULSE GENERATORS 658K AND 658T
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DXY
1987-11-04
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
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DXY
1987-10-15
VICOR, MODEL 410A
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DXY
1987-10-09
MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS
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DXY
1987-08-12
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
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DXY
1987-08-10
MEDTRONIC CLASSIX MODELS 8436/8437/8438
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DXY
1987-06-05
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
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DXY
1987-04-22
PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR
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DXY
1987-02-19
ASTRA T2, T4 AND T6
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DXY
1987-02-10
MULTILITH 3 MODELS 1350, 3350, 1370, 3370
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DXY
1987-02-03
DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS
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DXY
1987-01-12
EDP-20 PACEMAKER
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DXY
1987-01-02
MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE
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DXY
1986-12-10
NEOS-M VS-1 PULSE GENERATOR
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DXY
1986-12-10
TRIOS-M VS-1 PULSE GENERATOR
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DXY
1986-10-08
MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)
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DXY
1986-10-08
CORDIS MULTICOR II MODEL 402D PACER
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DXY
1986-10-08
MODIFICATION OF STERILITY CYCLE PARAMETERS
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DXY
1986-09-24
MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE
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DXY
1986-09-04
ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN.
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DXY
1986-08-28
CERYX PACEMAKER MODELS 114, 314 & 614
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DXY
1986-08-08
NEOS VS-1, PULSE GENERATOR
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DXY
1986-08-04
MIKROS, MIKROS VS-1, PULSE GENERATOR
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DXY
1986-07-16
ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR
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DXY
1986-07-15
PINNACLE MULTI-PROGRAMMABLE PACING SYS
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DXY
1986-07-01
MODIFIED MODELS 8320/8322/8329/8316/8317/8318
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