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 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 Oct 17, 1988
MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER
K884023
Cardiac Control Systems, Inc.
Cardiovascular · 25d
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 Apr 11, 1988
MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS
K880326
Cardiac Control Systems, Inc.
Cardiovascular · 76d
Cleared Mar 31, 1988
MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER
K880422
Cardiac Control Systems, Inc.
Cardiovascular · 59d
Cleared Dec 29, 1987
CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK.
K874158
Cardiac Control Systems, 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
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