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
49–72 of 461
Cleared Feb 19, 1987
ASTRA T2, T4 AND T6
K865013
Cardiac Pacemakers, Inc.
Cardiovascular · 58d
Cleared Feb 10, 1987
MULTILITH 3 MODELS 1350, 3350, 1370, 3370
K863898
Ela Medical, Inc.
Cardiovascular · 126d
Cleared Feb 03, 1987
DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS
K862226
Pacesetter Systems
Cardiovascular · 237d
Cleared Jan 12, 1987
EDP-20 PACEMAKER
K860036
Biotronik Sales, Inc.
Cardiovascular · 371d
Cleared Jan 02, 1987
MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE
K862459
Medtronic Vascular
Cardiovascular · 186d
Cleared Dec 10, 1986
TRIOS-M VS-1 PULSE GENERATOR
K863878
Biotronik Sales, Inc.
Cardiovascular · 65d
Cleared Dec 10, 1986
NEOS-M VS-1 PULSE GENERATOR
K863879
Biotronik Sales, Inc.
Cardiovascular · 65d
Cleared Oct 08, 1986
CORDIS MULTICOR II MODEL 402D PACER
K863417
Cordis Corp.
Cardiovascular · 35d
Cleared Sep 24, 1986
MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE
K863418
Intermedics, Inc.
Cardiovascular · 21d
Cleared Sep 04, 1986
ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN.
K862974
Medtronic Vascular
Cardiovascular · 29d
Cleared Aug 08, 1986
NEOS VS-1, PULSE GENERATOR
K860921
Biotronik Sales, Inc.
Cardiovascular · 150d
Cleared Aug 04, 1986
MIKROS, MIKROS VS-1, PULSE GENERATOR
K860922
Biotronik Sales, Inc.
Cardiovascular · 146d
Cleared Jul 16, 1986
ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR
K860585
Cardiac Pacemakers, Inc.
Cardiovascular · 148d
Cleared Jul 01, 1986
MODIFIED MODELS 8320/8322/8329/8316/8317/8318
K861719
Medtronic Vascular
Cardiovascular · 60d
Cleared Jun 26, 1986
PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY
K861422
Pacesetter Systems
Cardiovascular · 71d
Cleared Jun 17, 1986
MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN
K862037
Medtronic Vascular
Cardiovascular · 20d
Cleared Jun 17, 1986
MODIFY LABEL/SPECTRAX S & SX IMPLANT PULSE GENER
K862038
Medtronic Vascular
Cardiovascular · 20d
Cleared Jun 17, 1986
MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN
K862071
Medtronic Vascular
Cardiovascular · 18d
Cleared May 28, 1986
IMPLANT PROG PULSE GENERATOR, UNIPOLAR & BIPOLAR
K860573
Telectronics, Inc.
Cardiovascular · 103d
Cleared May 02, 1986
PROGRAMALITH III PULSE GENERATOR
K861140
Pacesetter Systems
Cardiovascular · 37d
Cleared Mar 31, 1986
UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762
K852973
Ela Medical, Inc.
Cardiovascular · 259d
Cleared Mar 17, 1986
MEDTRONIC MODELS 8316,8317,8318 PULSE GENERATORS
K855147
Medtronic Vascular
Cardiovascular · 83d
Cleared Mar 07, 1986
PHOENIX MODELS 250/251 PULSE GENERATORS
K855081
Pacesetter Systems
Cardiovascular · 78d
Cleared Feb 28, 1986
ALTERNATE STERILE PKG IMPLANTABLE PULSE GENERATORS
K854482
Medtronic Vascular
Cardiovascular · 113d