Product code JOQ

Device name: Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Medical specialty: Cardiovascular
Device class: 2
Regulation number: 870.1750
Review panel: CV
Implant: N
Life sustaining/supporting: Y
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

PMA, Device, Applicant table
PMA	Device	Applicant	Decision date
P920032S005	MICRO-PACE DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER	Pace Medical	2000-02-02
P920032S004	MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER	Pace Medical	1998-02-27
P920032S003	MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER	Pace Medical	1996-07-19
P920032S002	MICRO-PACE MODEL 4553 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKER	Pace Medical	1996-04-26
P920032S001	MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER	Pace Medical	1995-08-28
P920032	MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER	Pace Medical	1994-03-10

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K173439	Bloom2 Programmable Electrophysiology Stimulator	Fischer Medical	2018-03-29
K092913	EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04	Ep Medsystems	2009-10-16
K072200	STIMLAB	Micropace Pty, Ltd.	2007-10-26
K070743	Z6 STIMULATOR	St Cardio Technologies, LLC	2007-07-02
K041442	EP-4 CLINICAL STIMUTATOR	Ep Medsystems	2004-09-14
K040207	EP-4 CLINICAL STIMULATOR	Ep Medsystems	2004-02-27
K011826	EPS320 CARDIAC STIMULATOR	Micropace Pty, Ltd.	2002-01-24
K991293	EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR	Fischer Medical Technologies, Inc.	2000-05-05
K963579	PACE-1A CARDIAC STIMULATOR	Radionics, Inc.	1996-11-08
K935590	EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR	Ep Medical, Inc.	1994-05-05
K900553	CONSTANT CURRENT STIMULATOR MODEL 022101	Ep Technologies, Inc.	1990-03-13
K893094	HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM	Heartware Intl. Corp.	1989-10-02
K861368	MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR	Medtronic Vascular	1986-08-04
K852746	EXTERNAL PACEMAKER TELECTRONICS TE200	Seamed Corp.	1985-09-12
K844815	CORDIS ELECTROPHYSIOLOGY STIMULATOR	Cordis Corp.	1985-06-11
K851091	MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR	Medtronic Vascular	1985-04-16
K843718	PROGRAMMABLE STIMULATOR 5326	Medtronic Vascular	1984-09-27
K833421	PROGRAMMABLE STIMULATOR 2352	Medtronic Vascular	1984-01-30

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
05415067002709	EP-4™	ST. JUDE MEDICAL, INC.	2025-09-11
05415067007865	EP-4™	ST. JUDE MEDICAL, INC.	2025-09-11
05415067007872	EP-4™	ST. JUDE MEDICAL, INC.	2025-09-11
05415067007889	EP-4™	ST. JUDE MEDICAL, INC.	2025-09-11
05415067051820	EP-4™	ST. JUDE MEDICAL, INC.	2025-09-11
05415067051837	EP-4™	ST. JUDE MEDICAL, INC.	2025-09-11
05414734219136	EP-4™	ST. JUDE MEDICAL, INC.	2025-09-11
00863019000368	Bloom2	Fischer Medical	2021-02-23
00863019000351	Bloom2	Fischer Medical	2019-01-25
00863019000344	Bloom2	Fischer Medical	2019-01-25
00863019000337	Bloom2	Fischer Medical	2019-01-25
05414734030236	EP-4™	ST. JUDE MEDICAL, INC.	2018-12-14
05415067018069	WorkMate Claris™	ST. JUDE MEDICAL, INC.	2018-11-09
05415067018076	WorkMate Claris™	ST. JUDE MEDICAL, INC.	2018-11-09
09349714004739	ORLAB	MICROPACE PTY LIMITED	2016-09-23
00863019000306	Bloom	Fischer Medical	2016-09-12
00863019000313	Bloom	Fischer Medical	2016-09-12
00863019000320	Bloom	Fischer Medical	2016-09-12
09349714004708	Micropace	MICROPACE PTY LIMITED	2016-07-01
09349714004630	StimLab	MICROPACE PTY LIMITED	2016-07-01
09349714004623	Micropace	MICROPACE PTY LIMITED	2016-07-01
05414734219112	EP-4™	ST. JUDE MEDICAL, INC.	2016-04-22
05414734208741	EP-4™	ST. JUDE MEDICAL, INC.	2016-04-15
05414734208758	EP-4™	ST. JUDE MEDICAL, INC.	2016-04-15

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