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 Jun 26, 1984
PULSE GENERATOR 688B & 688L
K841231
Siemens Elema AB
Cardiovascular · 96d
Cleared Jun 25, 1984
PULSE GENERATOR 698, 698B & 698L
K841229
Siemens Elema AB
Cardiovascular · 95d
Cleared Jun 25, 1984
NEOS M
K841636
Biotronik Sales, Inc.
Cardiovascular · 67d
Cleared Jun 25, 1984
PULSE GENERATOR KALOS-04
K841950
Biotronik Sales, Inc.
Cardiovascular · 52d
Cleared May 30, 1984
PRIMA 236-02 NONPROGRAMMABLE CARDIAC
K841404
Intermedics, Inc.
Cardiovascular · 57d
Cleared May 16, 1984
IMPLANTABLE PROGRAMMABLE PULSE GENER
K840737
Telectronics, Inc.
Cardiovascular · 85d
Cleared May 16, 1984
QUANTUM, UNIPOLAR, MULTI-PROGRAMMABLE
K841073
Intermedics, Inc.
Cardiovascular · 65d
Cleared May 16, 1984
CARDIAC PULSE GENERATOR 254-18
K841074
Intermedics, Inc.
Cardiovascular · 65d
Cleared May 16, 1984
CARCIAC PULSE GENERATOR 254-20
K841075
Intermedics, Inc.
Cardiovascular · 65d
Cleared May 02, 1984
PACEMAKER 147 VVI-THE OPTINIA
K840701
Telectronics, Inc.
Cardiovascular · 75d
Cleared Feb 10, 1984
IMPLANTABLE BIPOLAR CARDIAC PULSE GEN
K833427
Telectronics, Inc.
Cardiovascular · 129d
Cleared Feb 10, 1984
IMPLANTABLE UNIPOLAR CARDIAC PULSE GEN
K833428
Telectronics, Inc.
Cardiovascular · 129d
Cleared Dec 16, 1983
IMPLANTABLE PULSE GENERATOR
K834096
Intermedics, Inc.
Cardiovascular · 18d
Cleared Dec 01, 1983
OPTIMA MDT PULSE GENERATOR W/TELEMETRY
K833798
Telectronics, Inc.
Cardiovascular · 31d
Cleared Nov 14, 1983
PRIMA-UNIPOLAR CARDIAC PULSE GENERAT
K832914
Intermedics, Inc.
Cardiovascular · 77d
Cleared Oct 28, 1983
SILICONE RUBBER ISOLATION SLEEVE 350-01
K833199
Intermedics, Inc.
Cardiovascular · 39d
Cleared Oct 27, 1983
PACEMAKER PROGRAMMER #2032
K831859
Vitatron Medical BV
Cardiovascular · 139d
Cleared Oct 27, 1983
GENERATOR, PULSE, PACEMAKER #532
K831860
Vitatron Medical BV
Cardiovascular · 139d
Cleared Oct 27, 1983
SILICONE RUBBER ISOLATION SLEEVE 351-01
K833198
Intermedics, Inc.
Cardiovascular · 38d
Cleared Oct 12, 1983
QUANTUM BIPOLAR CARDIAC PULSE GENERATOR
K831633
Intermedics, Inc.
Cardiovascular · 145d
Cleared Oct 04, 1983
MODEL 329T PROGRAMMABLE, BIPOLAR CARDI
K832893
Cook Pacemaker Corp.
Cardiovascular · 39d
Cleared Aug 16, 1983
IMPLANTABLE PROGRAM. CARDIAC PULSE GEN
K831771
Telectronics, Inc.
Cardiovascular · 75d
Cleared Aug 08, 1983
MODEL 327T UNIPOLAR CARDIAC PULSE GEN
K832052
Cook Pacemaker Corp.
Cardiovascular · 42d
Cleared Jul 12, 1983
COMMAND ULTRA II
K831216
Cardiac Pacemakers, Inc.
Cardiovascular · 89d