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
145–168 of 461
Cleared Jun 15, 1983
COMMAND ULTRA I
K831161
Cardiac Pacemakers, Inc.
Cardiovascular · 65d
Cleared May 25, 1983
NEDS-01 & EPR-500
K830862
Biotronik Sales, Inc.
Cardiovascular · 68d
Cleared Mar 24, 1983
IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 242
K823878
Pacesetter Systems
Cardiovascular · 87d
Cleared Mar 24, 1983
IMPLANTABLE BIPOLAR CARDIAC PULSE GEN
K830390
Telectronics, Inc.
Cardiovascular · 42d
Cleared Mar 17, 1983
COMMAND ULTRA II
K830382
Cardiac Pacemakers, Inc.
Cardiovascular · 41d
Cleared Mar 17, 1983
UNILITH PULSE GENERATOR VVI #7542
K830401
Ela Medical, Inc.
Cardiovascular · 38d
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 Feb 18, 1983
AFP SYSTEM PULSE GENERATOR MODEL 261/262
K822639
Pacesetter Systems
Cardiovascular · 170d
Cleared Feb 18, 1983
AFP PULSE GENERATOR
K823559
Pacesetter Systems
Cardiovascular · 78d
Cleared Dec 22, 1982
TELEMETRY DECODER #540-02
K823678
Intermedics, Inc.
Cardiovascular · 16d
Cleared Nov 01, 1982
KALOS-03 BIPOLAR
K822907
Biotronik Sales, Inc.
Cardiovascular · 32d
Cleared Oct 04, 1982
ENERTRAX MODEL 7100E
K822297
Medtronic Vascular
Cardiovascular · 62d
Cleared Oct 04, 1982
COMMAND NP
K822309
Cardiac Pacemakers, Inc.
Cardiovascular · 62d
Cleared Aug 06, 1982
MEDTRONIC ENERTRAX MODEL 7100
K822147
Medtronic Vascular
Cardiovascular · 15d
Cleared May 07, 1982
PROGRAMMALITH II, #225 & 226
K821003
Pacesetter Systems
Cardiovascular · 28d
Cleared May 07, 1982
PULSE GENERATOR
K821073
Biotronik Sales, Inc.
Cardiovascular · 21d
Cleared Apr 15, 1982
PULSE GENERATOR 678 B
K820657
Siemens Elema AB
Cardiovascular · 37d
Cleared Apr 09, 1982
IMPLANTABLE, MULTIPROGRAMMABLE
K820774
Biotronik Sales, Inc.
Cardiovascular · 17d
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 Mar 15, 1982
COMMAND ULTRA I
K820231
Cardiac Pacemakers, Inc.
Cardiovascular · 46d
Cleared Feb 12, 1982
MEDICAL MULTILITH PULSE GENERA-1140
K813246
Ela Medical, Inc.
Cardiovascular · 86d
Cleared Jan 22, 1982
COMMAND P5
K813534
Cardiac Pacemakers, Inc.
Cardiovascular · 36d