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
313–336 of 461
Cleared Sep 12, 1979
MODEL 228-02 THINLITH II PACEMAKER, BIPO
K791379
Intermedics, Inc.
Cardiovascular · 50d
Cleared Sep 04, 1979
IMPLANTABLE PULSE GENERATOR PACEMAKER
K791417
Intermedics, Inc.
Cardiovascular · 39d
Cleared Aug 10, 1979
PULSE GENERATOR, R WAVE DEMAND
K790141
Pacesetter Systems
Cardiovascular · 203d
Cleared Aug 10, 1979
MDL-201A & T DL-201A PULSE GENERATOR
K790428
Pacesetter Systems
Cardiovascular · 162d
Cleared Aug 10, 1979
BJORK-SHILEY AORTIC GRAFT VALVE PROSTH
K791225
Shiley, Inc.
Cardiovascular · 38d
Cleared Aug 03, 1979
ARCO PROGAMMABLE PACEMAKER SYSTEM
K791147
Arco Medical Products Co.
Cardiovascular · 46d
Cleared Jul 30, 1979
UNILITH PULSE GENERATOR
K791219
Ela Medical, Inc.
Cardiovascular · 27d
Cleared Jul 24, 1979
PULSE GENERATOR, MODEL 171
K782161
Telectronics, Inc.
Cardiovascular · 215d
Cleared Jul 24, 1979
BATTERY CHARGER, 171 PACEMAKER
K782162
Telectronics, Inc.
Radiology · 215d
Cleared Jul 10, 1979
ARCOLITH 4000
K791165
Arco Medical Products Co.
Cardiovascular · 15d
Cleared Jun 20, 1979
MODELS 2411/2418 VENTRICULAR-INHIBITED
K791093
Medtronic Vascular
Cardiovascular · 8d
Cleared Jun 01, 1979
VITALITH S 3000 SERIES
K790666
Vitatron Medical BV
Cardiovascular · 56d
Cleared May 31, 1979
CARDIAC PULSE GENERATOR, 16 SERIES
K790867
Telectronics, Inc.
Cardiovascular · 24d
Cleared May 25, 1979
GENERATOR, 16 SERIES, MODIFIED TOP CAP
K790868
Telectronics, Inc.
Cardiovascular · 18d
Cleared May 16, 1979
OMNI-STANICOR-(THETA) MODEL 217
K790690
Cordis Corp.
Cardiovascular · 36d
Cleared May 08, 1979
PULSE GENERATOR MODEL 61 AND 128
K790562
Ela Medical, Inc.
Cardiovascular · 50d
Cleared Apr 26, 1979
PACEMAKERS WITHOUT SILASTIC COATING
K790764
Telectronics, Inc.
Cardiovascular · 7d
Cleared Mar 20, 1979
MICROLITH MODELS 505
K790432
Cardiac Pacemakers, Inc.
Cardiovascular · 18d
Cleared Feb 26, 1979
MINILITH AND MICROLITH
K790276
Cardiac Pacemakers, Inc.
Cardiovascular · 18d
Cleared Feb 08, 1979
PULSE GENERATOR, IMPLANTABLE CARDIAC
K782149
Telectronics, Inc.
Cardiovascular · 44d
Cleared Feb 08, 1979
BIPOLAR, STANICOR LAMBDA MODEL 236,235
K790014
Cordis Corp.
Cardiovascular · 36d
Cleared Jan 24, 1979
ISOLATION SLEEVE, MODEL 349-01
K790098
Intermedics, Inc.
Cardiovascular · 8d
Cleared Jan 24, 1979
ISOLATION SLEEVE, MODEL 347-01
K790099
Intermedics, Inc.
Cardiovascular · 8d
Cleared Jan 24, 1979
ISOLATION SLEEVE, MODEL 348-01
K790100
Intermedics, Inc.
Cardiovascular · 8d