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
145–168 of 461
Cleared Mar 21, 1985
CCS IMPLANTABLE MAESTRO SERIES 100-HEART PACEMAKER
K850384
Cardiac Control Systems, Inc.
Cardiovascular · 48d
Cleared Mar 01, 1985
EKG TRANSMITTER MODEL 5134
K842051
Instromedix, Inc.
Cardiovascular · 283d
Cleared Mar 01, 1985
COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM
K850656
Cook Pacemaker Corp.
Cardiovascular · 10d
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
Cleared Aug 03, 1984
LEPTOS
K841635
Biotronik Sales, Inc.
Cardiovascular · 106d
Cleared Jul 11, 1984
COOK PACEMAKER 215 UNIPOLAR CARDIAC-
K841928
Cook Pacemaker Corp.
Cardiovascular · 62d
Cleared Jul 11, 1984
COOK PACEMAKER 216 BIPOLAR CARDIAC -
K841983
Cook Pacemaker Corp.
Cardiovascular · 57d
Cleared Jul 06, 1984
PULSE GENERATOR 678L
K841233
Siemens Elema AB
Cardiovascular · 106d
Cleared Jul 06, 1984
COOK PACEMAKER CORP. 115 UNIPOLAR CARDI
K842081
Cook Pacemaker Corp.
Cardiovascular · 44d
Cleared Jun 26, 1984
PULSE GENERATOR 728, 728B & 728L
K841226
Siemens Elema AB
Cardiovascular · 96d
Cleared Jun 26, 1984
PULSE GENERATOR 718B & 718L
K841228
Siemens Elema AB
Cardiovascular · 96d