DXY · Class III · 21 CFR 870.3610

FDA Product Code DXY: Implantable Pacemaker Pulse-generator

Leading manufacturers include Medtronic Vascular, Intermedics, Inc. and Telectronics, Inc..

461
Total
461
Cleared
80d
Avg days
1976
Since
461 devices
97–120 of 461
Cleared May 16, 1985
PROGRAMALITH III MODEL 249 PULSE GENERATOR
K851861
Pacesetter Systems
Cardiovascular · 20d
Cleared May 15, 1985
PROGRAMALITH III 240 PULSE GENERATOR
K850464
Pacesetter Systems
Cardiovascular · 97d
Cleared Apr 18, 1985
LEPTOS PULSE GENERATOR
K844794
Biotronik Sales, Inc.
Cardiovascular · 129d
Cleared Apr 18, 1985
NEOS-M PULSE GENERATOR
K844795
Biotronik Sales, Inc.
Cardiovascular · 129d
Cleared Apr 18, 1985
NEOS - PULSE GENERATOR
K844812
Biotronik Sales, Inc.
Cardiovascular · 128d
Cleared Apr 18, 1985
KALOS-04 PULSE GENERATOR
K844841
Biotronik Sales, Inc.
Cardiovascular · 127d
Cleared Apr 18, 1985
NEOS-LP PULSE GENERATOR
K844842
Biotronik Sales, Inc.
Cardiovascular · 127d
Cleared Apr 04, 1985
QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR
K850252
Telectronics, Inc.
Cardiovascular · 72d
Cleared Apr 04, 1985
IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II
K851081
Telectronics, Inc.
Cardiovascular · 17d
Cleared Apr 01, 1985
PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR
K850651
Pacesetter Systems
Cardiovascular · 41d
Cleared Feb 08, 1985
SUPRIMA 253-21 IMPLANTABLE PULSE GENERATOR
K844793
Intermedics, Inc.
Cardiovascular · 60d
Cleared Feb 08, 1985
MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR
K844957
Medtronic Vascular
Cardiovascular · 49d
Cleared Feb 08, 1985
MEDTRONIC MODELS 8432/8433/8434 - PACEMAKER PULSE
K844958
Medtronic Vascular
Cardiovascular · 49d
Cleared Jan 10, 1985
MULTILITH PULSE GENERATORS, 1141 & 2141
K842193
Ela Medical, Inc.
Cardiovascular · 220d
Cleared Jan 10, 1985
VIVALITH II 301 PULSE GENERATOR
K844334
Pacesetter Systems
Cardiovascular · 64d
Cleared Dec 03, 1984
PULSE GENERATOR 689, 689B & 689L
K841225
Siemens Elema AB
Cardiovascular · 256d
Cleared Dec 03, 1984
PULSE GENERATOR 686, 686B 686L
K841230
Siemens Elema AB
Cardiovascular · 256d
Cleared Dec 03, 1984
PULSE GENERATOR 696, 696B & 696L
K841232
Siemens Elema AB
Cardiovascular · 256d
Cleared Nov 29, 1984
MULTILITH 2 PULSE GENERATOR 1141 & 2141
K842220
Ela Medical, Inc.
Cardiovascular · 177d
Cleared Oct 26, 1984
IMPLANTABLE PROGRAMMABLE PULSE GENERAT
K842473
Telectronics, Inc.
Cardiovascular · 123d
Cleared Oct 17, 1984
ASTRA 2, ASTRA 3, 4 & 6
K842394
Cardiac Pacemakers, Inc.
Cardiovascular · 120d
Cleared Oct 17, 1984
MEDTRONIC 5984-5984LP-5985
K843837
Medtronic Vascular
Cardiovascular · 16d
Cleared Aug 29, 1984
MEDTRONIC 8437/8438
K843089
Medtronic Vascular
Cardiovascular · 23d
Cleared Aug 06, 1984
NEOS LP
K841633
Biotronik Sales, Inc.
Cardiovascular · 109d