DXY · Class III · 21 CFR 870.3610

FDA Product Code DXY: Implantable Pacemaker Pulse-generator

Leading manufacturers include Medtronic Vascular, Intermedics, Inc. and Cordis Corp..

461
Total
461
Cleared
80d
Avg days
1976
Since
461 devices
49–72 of 461
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 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 May 30, 1984
PRIMA 236-02 NONPROGRAMMABLE CARDIAC
K841404
Intermedics, Inc.
Cardiovascular · 57d
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 Dec 16, 1983
IMPLANTABLE PULSE GENERATOR
K834096
Intermedics, Inc.
Cardiovascular · 18d
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
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 Mar 16, 1983
MEDTRONIC MODELS 59401 5941
K823831
Medtronic Vascular
Cardiovascular · 85d
Cleared Mar 10, 1983
CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC
K823863
Intermedics, Inc.
Cardiovascular · 78d
Cleared Dec 22, 1982
TELEMETRY DECODER #540-02
K823678
Intermedics, Inc.
Cardiovascular · 16d
Cleared Oct 04, 1982
ENERTRAX MODEL 7100E
K822297
Medtronic Vascular
Cardiovascular · 62d
Cleared Aug 06, 1982
MEDTRONIC ENERTRAX MODEL 7100
K822147
Medtronic Vascular
Cardiovascular · 15d
Cleared Apr 09, 1982
QUANTUM MODELS 253-09, 254-09 254-10
K820853
Intermedics, Inc.
Cardiovascular · 14d
Cleared Mar 18, 1982
MULTICOR (GAMMA) 402 CARDIAC PACER
K820356
Cordis Corp.
Cardiovascular · 38d
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