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
169–192 of 461
Cleared Jan 22, 1982
SIEMENS-ELEMA PULSE GENERATOR 659
K813576
Siemens Elema AB
Cardiovascular · 30d
Cleared Dec 10, 1981
SIEMENS-ELEMA PULSE GENERATOR 668 B
K812610
Siemens Corp.
Cardiovascular · 86d
Cleared Dec 10, 1981
BIPOLAR OPTIMA MP #255
K813079
Telectronics, Inc.
Cardiovascular · 38d
Cleared Dec 02, 1981
DIRECTIONAL BOOT
K813150
Pacesetter Systems
Cardiovascular · 26d
Cleared Oct 29, 1981
IMPLANTABLE VENTRICULAR-INHIBITED CARDI
K812790
Telectronics, Inc.
Cardiovascular · 24d
Cleared Oct 13, 1981
KALOS-03
K812218
Biotronik Sales, Inc.
Cardiovascular · 68d
Cleared Sep 23, 1981
CYBERLITH IX IMPLANTABLE PULSE GENERATOR
K801337
Intermedics, Inc.
Cardiovascular · 476d
Cleared Sep 23, 1981
TELEMETRY DECODER
K801339
Intermedics, Inc.
Cardiovascular · 476d
Cleared Sep 23, 1981
MEDTRONIC MODEL 2409
K812580
Medtronic Vascular
Cardiovascular · 13d
Cleared Sep 16, 1981
MEDTRONIC ENERTRAX MODEL 7100
K812096
Medtronic Vascular
Cardiovascular · 54d
Cleared Aug 31, 1981
MEDTRONIC SPECTRAX
K812153
Medtronic Vascular
Cardiovascular · 33d
Cleared Jul 27, 1981
COMMAND P5(BIPOLAR PULSE GENERATOR)
K811402
Cardiac Pacemakers, Inc.
Cardiovascular · 70d
Cleared Jul 20, 1981
ELA MEDICAL UNILITH 7540 PULSE GENERATOR
K810887
Ela Medical, Inc.
Cardiovascular · 110d
Cleared Jul 20, 1981
CORDIS OMNI-ARTICOR CARDIAC PACER #308
K811691
Cordis Corp.
Cardiovascular · 35d
Cleared Jul 01, 1981
UNIPOLAR SPECTRAX IMPL. PULSE GENERAT.
K811350
Medtronic Vascular
Cardiovascular · 49d
Cleared May 29, 1981
ELA MEDICAL UNILITH PULSE GENERATOR
K810142
Ela Medical, Inc.
Cardiovascular · 128d
Cleared May 29, 1981
MULTILITH PULSE GENERATOR #1140
K810489
Ela Medical, Inc.
Cardiovascular · 95d
Cleared May 27, 1981
MODELS 5976/5977 PACEMAKER PULSE GENER
K810677
Medtronic, Inc.
Cardiovascular · 75d
Cleared May 27, 1981
MEDTRONIC PULSE GENERATOR
K811123
Medtronic Vascular
Cardiovascular · 33d
Cleared May 27, 1981
INTERMEDICS CYBERLITH BIPOLAR CARDIAC
K811221
Intermedics, Inc.
Cardiovascular · 23d
Cleared May 15, 1981
MODELS 8420 THRU 8423 PACEMAKER GENER
K810734
Medtronic Vascular
Cardiovascular · 58d
Cleared May 01, 1981
THINLITH III UNIPOLAR CARDIAC PULSE GEN.
K810752
Intermedics, Inc.
Cardiovascular · 42d
Cleared May 01, 1981
MODEL 230-05 CYBERLITH I BIPOL. PULSE G.
K810800
Intermedics, Inc.
Cardiovascular · 39d
Cleared May 01, 1981
MODEL 230-06 CYBERLITH TM I BIPOLAR IN
K811066
Intermedics, Inc.
Cardiovascular · 14d