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
193–216 of 461
Cleared Apr 14, 1981
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE
K810603
Telectronics, Inc.
Cardiovascular · 39d
Cleared Apr 14, 1981
INSULATIVE COATING FOR CARD. PULSE GEN
K810901
Intermedics, Inc.
Cardiovascular · 11d
Cleared Apr 01, 1981
INTERMEDICS CYBERLITH I BIOPOLAR CARDI
K810383
Intermedics, Inc.
Cardiovascular · 47d
Cleared Apr 01, 1981
CYBERLITH I PULSE GENERATOR MODEL 253-04
K810385
Intermedics, Inc.
Cardiovascular · 47d
Cleared Mar 13, 1981
THINLITH II PULSE GNEERATOR MODEL 227-05
K810386
Intermedics, Inc.
Cardiovascular · 28d
Cleared Mar 05, 1981
STERILE PACKAGING
K810410
Telectronics, Inc.
Cardiovascular · 15d
Cleared Feb 12, 1981
MULTI-PROGRAMMABLE PACEMAKER & PROGRMR.
K801584
Medtronic Vascular
Cardiovascular · 216d
Cleared Feb 05, 1981
SIEMENS-ELEMA PULSE GENERATOR 678
K802864
Siemens Elema AB
Cardiovascular · 85d
Cleared Jan 29, 1981
SIEMENS-ELEMA MYOCARDIAL LEAD
K810036
Siemens Elema AB
Cardiovascular · 20d
Cleared Jan 22, 1981
IMPL. PROGRAMMABLE BIPOLAR CARD.GEN.#274
K803197
Telectronics, Inc.
Cardiovascular · 37d
Cleared Jan 07, 1981
CYBERLITH PROGRAMMER
K801338
Intermedics, Inc.
Cardiovascular · 217d
Cleared Dec 22, 1980
MICRO THIN-DII, #0521
K802352
Cardiac Pacemakers, Inc.
Cardiovascular · 88d
Cleared Dec 22, 1980
MICRO THIN-PII, #0523
K802353
Cardiac Pacemakers, Inc.
Cardiovascular · 88d
Cleared Dec 22, 1980
MICROTHIN-PII BIPOLAR PULSE GEN. #0623
K803034
Cardiac Pacemakers, Inc.
Cardiovascular · 21d
Cleared Dec 22, 1980
MICROTHIN-PII BIPOLAR PULSE GEN. #0621
K803035
Cardiac Pacemakers, Inc.
Cardiovascular · 21d
Cleared Dec 01, 1980
SIEMENS-ELEMA PULSE GENERATOR 668
K801324
Siemens Elema AB
Cardiovascular · 181d
Cleared Oct 31, 1980
MICROTHIN-DI BIPOLAR PULSE GENERATOR
K802409
Cardiac Pacemakers, Inc.
Cardiovascular · 28d
Cleared Oct 31, 1980
MICROTHIN-PI BIPOLAR PULSE GENERATOR
K802410
Cardiac Pacemakers, Inc.
Cardiovascular · 28d
Cleared Oct 03, 1980
SORIN PULSE GENERATOR, MODEL #LIT-214
K801640
Bentley Laboratories, Inc.
Cardiovascular · 78d
Cleared Sep 26, 1980
PROGRAMALITH #'S 221, 222, 221A & 222A
K801978
Pacesetter Systems
Cardiovascular · 38d
Cleared Sep 26, 1980
IMPLANTABLE VENTRICULAR-INHIB. C.P. GEN
K802028
Telectronics, Inc.
Cardiovascular · 36d
Cleared Sep 18, 1980
IMPLANTABLE PROGRAM. CARDIAC PACEMAKER
K800793
Telectronics, Inc.
Cardiovascular · 162d
Cleared Sep 16, 1980
SIEMENS-ELEMA PULSE GENERATOR 625
K801508
Siemens Elema AB
Cardiovascular · 78d
Cleared Sep 09, 1980
MEDTRONIC MODEL 2409
K800226
Medtronic Vascular
Cardiovascular · 217d