Product code KRG

Device name: Programmer, Pacemaker
Medical specialty: Cardiovascular
Device class: 3
Regulation number: 870.3700
Review panel: CV
Implant: N
Life sustaining/supporting: N
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
P010031S511	BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D	Medtronic Cardiac Rhythm Disease Management	2015-10-29
P010031S500	APPLICATION SOFTWARE, BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC ICD, INSYNC	Medtronic Cardiac Rhythm Disease Management	2015-06-04
P010031S413	BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D,VIVA/BRAVA/EVERA PROGRAMMER APPLICATION SOFTWARE	Medtronic Cardiac Rhythm Disease Management	2014-02-27
P890003S253	MEDTRONIC CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS	Medtronic, Inc.	2013-01-29
P880086S108	VICTORY PULSE GENERATOR MODELS: XL DR 5816, DR 5810 AND SR 5610	ABBOTT MEDICAL	2005-12-07
P880086S109	AFFINITY,IDENTITY,INTEGRITY & ENTITY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS	ABBOTT MEDICAL	2005-10-14
P830045S091	EPIC + DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND THE MODEL 3307 V 4.6M SOFTWARE	St. Jude Medical, Inc.	2004-04-09
P830045S090	VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR	St. Jude Medical, Inc.	2004-01-30
P830045S089	MODEL 3510 PROGRAMMER AND MODEL 3134 EXTERNAL VIDEO CABLE	St. Jude Medical, Inc.	2003-10-31
P830045S088	ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND MODEL 3307 V.4.5A SOFTWARE	St. Jude Medical, Inc.	2003-10-17
P830045S087	ADX PULSE GENERATOR	St. Jude Medical, Inc.	2003-08-15
P830045S086	IDENTITY ADX XL DC,SR/ADX VDR/ADX XL DR,DR,SR/VERITY ADX XL VDR/ADX XL DR,DR,DC/ADX XLSR,SR,SC	St. Jude Medical, Inc.	2003-05-09
P830045S084	EPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS	St. Jude Medical, Inc.	2003-04-23
P830045S085	IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A	St. Jude Medical, Inc.	2003-03-20
P900070S028	APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A)	St. Jude Medical, Cardiac Rhythm Management Divisi	2003-01-22
P880086S090	AV PLUS DX, MODEL 1368	ABBOTT MEDICAL	2003-01-22
P830045S083	APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A)	St. Jude Medical, Inc.	2003-01-22
P830045S082	MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE	St. Jude Medical, Inc.	2002-08-13
P830045S081	ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND B-235)	St. Jude Medical, Inc.	2002-07-30
P830045S080	ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM	St. Jude Medical, Inc.	2001-12-21
P830045S079	IDENTITY PULSE GENERATOR MODEL DR 5370	St. Jude Medical, Inc.	2001-11-27
P880006S034	REGENCY SC+ PULSE GENERATORS	St. Jude Medical, Inc.	2001-10-25
P830045S078	INTEGRITY AFX DR MODEL 5346	St. Jude Medical, Inc.	2001-10-02
P830045S077	MODEL 3307 VERSION 2.4A PROGRAMMER SOFTWARE	St. Jude Medical, Inc.	2001-09-05
P830045S076	INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE	St. Jude Medical, Inc.	2001-07-11
P830045S075	VENTRITEX ICD'S USING MODEL 3307, V2.1A PROGRAMMER SOFTWARE	St. Jude Medical, Inc.	2001-03-02
P830045S074	INTEGRITY DR MODEL 5336/INTEGRITY SR MODEL 5136	St. Jude Medical, Inc.	2000-12-12
P830045S073	VENTRITEX ICD'S	St. Jude Medical, Inc.	2000-11-27
P830045S072	INTEGRITY/BRADYCARDIA REFERENCE/PATIENT MANUAL	St. Jude Medical, Inc.	2000-10-02
P900070S027	TRILOGY/SOLUS II/PARAGON III/PHOENIX III	St. Jude Medical, Cardiac Rhythm Management Divisi	2000-09-07

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K933278	INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04	Intermedics, Inc.	1995-03-15
K884522	MODEL 5650 OPTIMATE PERSONAL PROGRAMMER	Teletronics, Inc.	1989-08-25
K880738	MODEL 2331T PATIENT PROGRAMMER	Medtronic Vascular	1988-11-17
K882429	MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004	Tpl-Cordis, Inc.	1988-07-22
K864712	MODEL 1740 PERSONAL POCKET PROGRAMMER	Telectronics, Inc.	1987-12-17
K871986	MODEL 5600B PROGRAMMER, PACEMAKER	Telectronics, Inc.	1987-06-24
K863046	ULTRA SOFTWARE MODULE: MODEL 2016	Cardiac Pacemakers, Inc.	1986-12-05
K863045	PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580	Cardiac Pacemakers, Inc.	1986-09-29
K860584	SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN	Cardiac Pacemakers, Inc.	1986-06-06
K860546	DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37	Pacesetter Systems	1986-04-23
K844484	HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA	Vitatron Medical BV	1985-07-24
K844483	TP 1	Vitatron Medical BV	1985-04-19
K844485	CERYX6, 611, CERYX 3 311 & CERYX 1 111	Vitatron Medical BV	1985-04-19
K842364	HANDHELD PACEMAKER PROGRAMMER & SOFTWAR	Cardiac Pacemakers, Inc.	1984-09-24
K820230	PACEMAKER PROGRAMMER 2030	Cardiac Pacemakers, Inc.	1982-03-15
K812761	FLOW-DIRECTED BALLOON THERMODILUTION	Nova Medical Specialties	1981-11-02
K812813	INTERMEDICS PROGRAMMER, MODEL 522-03	Intermedics, Inc.	1981-10-27
K811217	PACEMAKER PROGRAMMER #2010	Cardiac Pacemakers, Inc.	1981-07-20
K810552	CORDIS PACEMAKER PROGRAMMERS 255A & 256A	Cordis Corp.	1981-03-20
K800376	EPR-200 PROGRAMMER MODEL 010	Biotronik Sales, Inc.	1980-04-21
K792580	PACEMAKER PROGRAMMER	Cardiac Pacemakers, Inc.	1979-12-19
K791419	OMNICOR PROGRAMMER MODEL 222C	Cordis Corp.	1979-11-27
K790220	PACEMAKER PROGRAMMER	Intermedics, Inc.	1979-07-31
K780175	RATE PROGRAMMER MODEL 520	Intermedics, Inc.	1978-04-21
K771855	OMNICOR PROGRAMMER MODEL 222A	Cordis Corp.	1977-10-07

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00643169720312	Viva™ XT CRT-D	MEDTRONIC, INC.	2017-09-15
00643169720206	Viva™ Quad S CRT-D	MEDTRONIC, INC.	2017-09-15
00643169720145	Viva™ Quad S CRT-D	MEDTRONIC, INC.	2017-09-15
00643169703247	NA	MEDTRONIC, INC.	2016-10-08
00643169530195	Viva™ S CRT-D	MEDTRONIC, INC.	2015-05-15
00643169530188	Viva™ S CRT-D	MEDTRONIC, INC.	2015-05-15
00643169530171	Viva™ Quad XT CRT-D	MEDTRONIC, INC.	2015-05-15
00643169530164	Viva™ Quad XT CRT-D	MEDTRONIC, INC.	2015-05-15
00643169530157	Viva™ XT CRT-D	MEDTRONIC, INC.	2015-05-15
00643169530140	Viva™ XT CRT-D	MEDTRONIC, INC.	2015-05-15
00643169007185	Viva™ S CRT-D	MEDTRONIC, INC.	2014-09-23
00643169369030	CareLink Encore™	MEDTRONIC, INC.	2014-09-23
00643169017993	Viva™ Quad S CRT-D	MEDTRONIC, INC.	2014-09-23
00643169007239	Viva™ XT CRT-D	MEDTRONIC, INC.	2014-09-23
00643169007222	Viva™ Quad XT CRT-D	MEDTRONIC, INC.	2014-09-23
00613994119995	NA	MEDTRONIC, INC.	2014-09-23
00643169007178	Viva™ S CRT-D	MEDTRONIC, INC.	2014-09-23
00643169007161	Viva™ Quad S CRT-D	MEDTRONIC, INC.	2014-09-23
00613994987099	Consulta® CRT-D	MEDTRONIC, INC.	2014-09-23
00613994987037	Protecta™ CRT-D	MEDTRONIC, INC.	2014-09-23
00613994987006	Protecta™ XT CRT-D	MEDTRONIC, INC.	2014-09-23
00613994909688	CareLink Encore™	MEDTRONIC, INC.	2014-09-23
00613994714800	Maximo® II CRT-D	MEDTRONIC, INC.	2014-09-23
00613994714701	Consulta® CRT-D	MEDTRONIC, INC.	2014-09-23
00613994714619	Protecta™ CRT-D	MEDTRONIC, INC.	2014-09-23
00613994714589	Protecta™ XT CRT-D	MEDTRONIC, INC.	2014-09-23
00613994581594	Medtronic CareLink® Programmer	MEDTRONIC, INC.	2014-09-23
00613994581570	Medtronic CareLink® Programmer	MEDTRONIC, INC.	2014-09-23
00613994362896	NA	MEDTRONIC, INC.	2014-09-23
00613994175397	Medtronic CareLink® Programmer	MEDTRONIC, INC.	2014-09-23

Product code KRG

Related PMA Records#

Related 510(k) Records#

Related GUDID Devices#