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
289–312 of 461
Cleared Apr 16, 1980
CYBERLITH IMPLANTABLE PULSE GEN. #253-02
K800644
Intermedics, Inc.
Cardiovascular · 23d
Cleared Apr 08, 1980
CYBERLITH IMPLANTABLE PULSE GEN. #253-04
K800645
Intermedics, Inc.
Cardiovascular · 15d
Cleared Mar 25, 1980
IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC
K800573
Telectronics, Inc.
Cardiovascular · 11d
Cleared Mar 17, 1980
ARCOLITH 3021-CARDIAC PULSE GENERATOR
K800326
Arco Medical Products Co.
Cardiovascular · 34d
Cleared Feb 05, 1980
PULSE GENERATOR, MODEL NO. LIT 222
K792526
Bentley Laboratories, Inc.
Cardiovascular · 60d
Cleared Feb 05, 1980
SORIN PULSE GENERATOR MODEL # LIT 214 H
K792565
Bentley Laboratories, Inc.
Cardiovascular · 60d
Cleared Jan 31, 1980
MICROTHIN-DI
K800026
Cardiac Pacemakers, Inc.
Cardiovascular · 24d
Cleared Jan 31, 1980
MICROTHIN-PI
K800027
Cardiac Pacemakers, Inc.
Cardiovascular · 24d
Cleared Jan 11, 1980
IMPLANTABLE BIPOLAR CARDIAC PULSE GEN.
K800030
Telectronics, Inc.
Cardiovascular · 4d
Cleared Dec 20, 1979
IMPLANTABLE PROGRAMMABLE UNIPOLAR
K792519
Telectronics, Inc.
Cardiovascular · 14d
Cleared Nov 29, 1979
CARDIAC PACEMAKER P4000 SER. & P1000
K791920
Vitatron Medical BV
Cardiovascular · 65d
Cleared Nov 29, 1979
ARCOLITH 2100-CARDIAC PULSE GENERATOR
K792216
Arco Medical Products Co.
Cardiovascular · 24d
Cleared Nov 29, 1979
ARCOLITH 3020-CARDIAC PULSE GENERATOR
K792299
Arco Medical Products Co.
Cardiovascular · 15d
Cleared Nov 15, 1979
MEDTRONIC MODELS 5984/5985
K791316
Medtronic Vascular
Cardiovascular · 126d
Cleared Oct 26, 1979
CARDIAC PACEMAKER C4000, C1000 SER.
K791921
Vitatron Medical BV
Cardiovascular · 31d
Cleared Oct 22, 1979
OMNI-STANICOR (THETA) MOD 237A
K791783
Cordis Corp.
Cardiovascular · 41d
Cleared Oct 22, 1979
IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD
K792052
Telectronics, Inc.
Cardiovascular · 7d
Cleared Sep 28, 1979
PULSE GENERATORS, MODELS 5983, 5989
K790068
Medtronic Vascular
Cardiovascular · 259d
Cleared Sep 28, 1979
CORDIS BIPOLAR PACER CONNECTOR SYSTEM
K791784
Cordis Corp.
Cardiovascular · 16d
Cleared Sep 27, 1979
ARCOLITH 2000
K791715
Arco Medical Products Co.
Cardiovascular · 27d
Cleared Sep 27, 1979
IMPLANTABLE VENTRICULAR-INHIBITED
K791727
Telectronics, Inc.
Cardiovascular · 27d
Cleared Sep 20, 1979
MODEL 221 PROGRAMALITH PULSE GENERATOR
K790873
Pacesetter Systems
Cardiovascular · 136d
Cleared Sep 20, 1979
PROGRAMMER, MEDTRONIC MODEL 5984/5985
K791181
Medtronic Vascular
Cardiovascular · 87d
Cleared Sep 19, 1979
IMPLANTABLE PULSE GENERATOR PACEMAKERS
K791568
Intermedics, Inc.
Cardiovascular · 40d