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
25–48 of 461
Cleared May 16, 1991
MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE
K905824
Cardiac Control Systems, Inc.
Cardiovascular · 136d
Cleared May 16, 1991
8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS
K911122
Intermedics, Inc.
Cardiovascular · 65d
Cleared May 07, 1991
TRIOS 02
K905087
Biotronik, GmbH & Co.
Cardiovascular · 175d
Cleared Jan 18, 1991
OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE
K903186
Telectronics Pacing Systems, Inc.
Cardiovascular · 183d
Cleared Jan 03, 1991
MEDTRONIC MODEL 5301B TEST CABLE
K904602
Medtronic Vascular
Cardiovascular · 85d
Cleared Jan 03, 1991
MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE
K904941
Cardiac Control Systems, Inc.
Cardiovascular · 63d
Cleared Dec 20, 1990
VACUUM BAKE CYCLE
K904892
Medtronic Vascular
Cardiovascular · 51d
Cleared Oct 23, 1990
IMPLANTABLE PULSE DEVICES
K903919
Medtronic Vascular
Cardiovascular · 60d
Cleared Sep 14, 1990
NEOS (TM) 02 B PULSE GENERATOR
K903081
Biotronik, GmbH & Co.
Cardiovascular · 64d
Cleared Jul 03, 1990
MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE.
K901535
Medtronic Vascular
Cardiovascular · 92d
Cleared Jul 03, 1990
MINIX, MINIX ST, NEW IC: L74
K902134
Medtronic Vascular
Cardiovascular · 54d
Cleared Apr 26, 1990
MODIFIED MODEL 5401B TEST CABLE
K900622
Medtronic Vascular
Cardiovascular · 77d
Cleared Mar 14, 1990
OPTIMA MPT MODEL 5281E AND MODEL 5282E
K897116
Telectronics Pacing Systems, Inc.
Cardiovascular · 78d
Cleared Mar 14, 1990
OPUS MODEL 4021, VVI, 5MM UNIPOLAR
K900461
Ela Medical, Inc.
Cardiovascular · 42d
Cleared Jan 26, 1990
MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR
K896809
Medtronic Vascular
Cardiovascular · 53d
Cleared Oct 17, 1989
LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD
K894494
Biotronik, GmbH & Co.
Cardiovascular · 90d
Cleared Sep 26, 1989
OPUS MODEL 4001
K894065
Ela Medical, Inc.
Cardiovascular · 110d
Cleared Sep 26, 1989
ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS
K895495
Medtronic Vascular
Cardiovascular · 29d
Cleared Sep 20, 1989
OPUS MODELS 4033 AND 4034
K894267
Ela Medical, Inc.
Cardiovascular · 90d
Cleared Sep 12, 1989
OPTIMA MPT AND SPT PACEMAKERS
K891231
Telectronics, Inc.
Cardiovascular · 189d
Cleared Aug 25, 1989
MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS
K894055
Medtronic Vascular
Cardiovascular · 79d
Cleared Aug 17, 1989
OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR
K894185
Telectronics Pacing Systems, Inc.
Cardiovascular · 62d
Cleared Mar 28, 1989
VS-1 MODEL NUMBER 251K PULSE GENERATOR
K885267
Pacesetter Systems
Cardiovascular · 96d
Cleared Mar 10, 1989
ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE
K890785
Cardiac Pacemakers, Inc.
Cardiovascular · 23d