FDA.report

Cardiac pulse generator programmer

Definition
An external device intended to enable a healthcare professional in a clinical setting to noninvasively change the settings of, and extract data from, an implanted cardiac pulse generator (e.g., pacemaker, pacemaker/defibrillator). It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software.
GUDID devices
111
Last updated
2026-01-29 15:31:08

Related Product Codes

CodeDeviceSpecialtyClassDevices
OSRPacemaker/Icd/Crt Non-Implanted ComponentsUnknown357
LWSImplantable Cardioverter Defibrillator (Non-Crt)Unknown332
NVZPulse Generator, Permanent, ImplantableUnknown39
KRGProgrammer, PacemakerCardiovascular36
DXYImplantable Pacemaker Pulse-GeneratorCardiovascular32
LWPImplantable Pulse Generator, Pacemaker (Non-Crt)Unknown31
MEBPump, Infusion, ElastomericGeneral Hospital21
MRMDefibrillator, Implantable, Dual-ChamberUnknown31
NIKDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)Unknown31
SEGLeadless Cardiac Resynchronization Therapy (Crt)Unknown31

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00802526627903LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATION33002026-01-21
00802526625206LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATION33002025-06-26
00859244007296WiSE CRT SystemEBR Systems, Inc.51002025-05-07
04035479179687NEOBIOTRONIK SE & Co. KG2202.U2023-01-16
04035479179694PSWBIOTRONIK SE & Co. KG2202.U2023-01-16
04035479188399NEO 2401.U/1BIOTRONIK SE & Co. KG4928172024-12-18
04035479186005NEOBIOTRONIK SE & Co. KG2401.U2024-06-17
04035479186012PSWBIOTRONIK SE & Co. KG2401.U2024-06-17
04035479184285NEOBIOTRONIK SE & Co. KG2303.U2023-12-15
04035479184292PSWBIOTRONIK SE & Co. KG2303.U2023-12-15
04035479185510Renamic Neo NEOexpressBIOTRONIK SE & Co. KG4867072023-12-15
00802526622601LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATION623300-1112023-10-27
00802526622908LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATION623300-1122023-10-27
04035479182960BIOTRONIKBIOTRONIK SE & Co. KGNEO 2302.U2023-08-23
04035479182977BIOTRONIKBIOTRONIK SE & Co. KGPSW 2302.U2023-08-23
04035479179632PSWBIOTRONIK SE & Co. KG2204.U2023-08-15
04035479179625NEOBIOTRONIK SE & Co. KG2204.U2023-08-08
08031527019611CPR4MICROPORT CRM SRLB100312023-06-26
10193494000131ON-Q* Pain Relief System with SOAKER* CatheterAvanos Medical, Inc.PS6506-N2023-06-23
08031527021089SmartViewMICROPORT CRM SRLSmartView 3.142023-06-23
00802526621215LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATION33002023-04-26
04035479181536NEOBIOTRONIK SE & Co. KG2301.U2023-04-19
04035479181543PSWBIOTRONIK SE & Co. KG2301.U2023-04-19
00802526620201LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATION33002022-11-18
04035479178017NEOBIOTRONIK SE & Co. KG2201.U/12022-04-18
04035479178024PSWBIOTRONIK SE & Co. KG2201.U/12022-04-18
00802526615108EMBLEM™ S-ICD ProgrammerBOSTON SCIENTIFIC CORPORATION32002022-01-26
00802526616105LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATION33002021-11-20
04035479164416PSWBIOTRONIK SE & Co. KG1804.U2019-03-18
04035479164423PSWBIOTRONIK SE & Co. KG1901.U2019-07-22
04035479162047PSWBIOTRONIK SE & Co. KG1802.U2018-10-25
04035479157708PSWBIOTRONIK SE & Co. KG1704.U2017-12-18
04035479160838PSWBIOTRONIK SE & Co. KG1801.U2018-08-20
04035479174781NEOBIOTRONIK SE & Co. KG2100.U2021-05-04
04035479174798PSWBIOTRONIK SE & Co. KG2100.U2021-05-04
04035479163068Renamic NeoBIOTRONIK SE & Co. KG4247232021-03-30
04035479150211PSWBIOTRONIK SE & Co. KG1503.U2016-01-04
04035479151843PSWBIOTRONIK SE & Co. KG1506.U2016-04-29
08031527013350CPR3MICROPORT CRM SRLCPR32014-09-05
08031527013367OrchestraMICROPORT CRM SRLPlus2014-09-05
08031527013886SmartviewMICROPORT CRM SRL2.40UG12014-09-05
08031527014210ORCHESTRA PLUS LINKMICROPORT CRM SRLNone2016-09-07
08031527014487SmartviewMICROPORT CRM SRL2.42UG12015-07-22
08031527016375SMARTVIEWMICROPORT CRM SRL2.50 UG12016-09-08
08031527016788SMARTVIEWMICROPORT CRM SRL2.52 UG12017-03-07
08031527017174SmartviewMICROPORT CRM SRL2.562017-11-23
04035479140380PSWBIOTRONIK SE & Co. KG1307.U2014-08-21
04035479140670PSWBIOTRONIK SE & Co. KG1304.U2014-12-04
04035479147143PSWBIOTRONIK SE & Co. KG1403.U2015-03-15
04035479149260PSWBIOTRONIK SE & Co. KG1501.U2015-04-15
04035479150204PSWBIOTRONIK SE & Co. KG1502.U2015-06-24
04035479152765PSWBIOTRONIK SE & Co. KG1507.U2016-05-09
04035479154165PSWBIOTRONIK SE & Co. KG1506.U/12016-06-16
04035479157678PSWBIOTRONIK SE & Co. KG1702.U2017-05-18
04035479157692PSWBIOTRONIK SE & Co. KG1703.U2017-09-06
04035479166397PSWBIOTRONIK SE & Co. KG1904.U2020-06-03
00802526610615NABOSTON SCIENTIFIC CORPORATION63952020-05-05
00802526077494NABOSTON SCIENTIFIC CORPORATION65772014-09-24
00802526600609NABOSTON SCIENTIFIC CORPORATION32032019-08-03
00802526608513LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATION33002019-07-25
00802526610202LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATION33002020-02-08
00802526611322ZOOM® LATITUDE®BOSTON SCIENTIFIC CORPORATION31202019-11-07
00802526610516EMBLEM™ S-ICD ProgrammerBOSTON SCIENTIFIC CORPORATION32002019-11-06
00802526610110LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATION33002019-11-04
00802526609206EMBLEM™ S-ICD ProgrammerBOSTON SCIENTIFIC CORPORATION32002019-06-14
05414734500661Merlin™ST. JUDE MEDICAL, INC.36502014-09-30
05414734502078Merlin™ST. JUDE MEDICAL, INC.Antenna2017-02-03
00885074301440Medtronic CareLink® ProgrammerMEDTRONIC, INC.2090W2014-09-23
00802526062568NABOSTON SCIENTIFIC CORPORATION29022014-09-24
00802526440908NABOSTON SCIENTIFIC CORPORATION31222014-09-24
00802526466564LATITUDE® Communicator Power SupplyBOSTON SCIENTIFIC CORPORATION64782014-09-24
00802526466571LATITUDE® Communicator Power SupplyBOSTON SCIENTIFIC CORPORATION64792014-09-24
00802526477201LATITUDE® Communicator Power SupplyBOSTON SCIENTIFIC CORPORATION64302014-09-24
00802526524806S-ICD® System Patient Screening ToolCAMERON HEALTH, INC.47442014-09-24
00802526536007NABOSTON SCIENTIFIC CORPORATION31302014-09-24
00802526542206Q TECHCAMERON HEALTH, INC.32002014-09-24
00802526542220NABOSTON SCIENTIFIC CORPORATION32032014-09-24
00802526542244Q-TECH™CAMERON HEALTH, INC.32042015-01-08
00802526553707HP OFFICEJET 100 Mobile PrinterCAMERON HEALTH, INC.47002014-09-24
00802526554308LATITUDE Consult ™ Power SupplyBOSTON SCIENTIFIC CORPORATION66932014-09-24