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 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 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
Cleared Feb 10, 1989
AFP MODEL 262T PULSE GENERATOR
K884733
Pacesetter Systems
Cardiovascular · 92d
Cleared Jan 26, 1989
OPTIMA MPT AND SPT PACEMAKERS
K884411
Telectronics, Inc.
Cardiovascular · 98d
Cleared Jan 25, 1989
UNILITH 3 MODELS 7580/7583/7680/7683
K883037
Ela Medical, Inc.
Cardiovascular · 190d
Cleared Nov 17, 1988
MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS
K883755
Medtronic Vascular
Cardiovascular · 76d
Cleared Nov 17, 1988
MINIX 8340, 8341, 8342 MINIX-ST 8330, 8331
K884215
Medtronic Vascular
Cardiovascular · 42d
Cleared Nov 14, 1988
OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024
K882391
Ela Medical, Inc.
Cardiovascular · 157d
Cleared Sep 23, 1988
CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066
K882427
Ela Medical, Inc.
Cardiovascular · 102d
Cleared Sep 14, 1988
PROLOG MP 658M PULSE GENERATOR
K883087
Pacesetter Systems
Cardiovascular · 55d
Cleared Sep 12, 1988
OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004
K882474
Ela Medical, Inc.
Cardiovascular · 89d
Cleared Sep 12, 1988
OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004
K882476
Ela Medical, Inc.
Cardiovascular · 89d
Cleared Jul 18, 1988
OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D
K881837
Telectronics, Inc.
Cardiovascular · 77d
Cleared Nov 23, 1987
QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.
K874394
Intermedics, Inc.
Cardiovascular · 26d
Cleared Nov 04, 1987
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K872766
Telectronics, Inc.
Cardiovascular · 113d
Cleared Nov 04, 1987
PROLOG MP PULSE GENERATORS 658K AND 658T
K872779
Pacesetter Systems
Cardiovascular · 113d
Cleared Oct 09, 1987
MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS
K873528
Intermedics, Inc.
Cardiovascular · 38d
Cleared Aug 12, 1987
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K871992
Telectronics, Inc.
Cardiovascular · 78d
Cleared Aug 10, 1987
MEDTRONIC CLASSIX MODELS 8436/8437/8438
K871866
Medtronic Vascular
Cardiovascular · 89d
Cleared Jun 05, 1987
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K871861
Telectronics, Inc.
Cardiovascular · 23d