FDA.reportPublic FDA data

Implantable cardiac device management application software

Definition
An application software program intended to be used in the management of an implantable cardiac device (e.g., monitor, pulse generator, pacemaker, defibrillator) by enabling computer-assisted functionality typically in one or more of the following areas: device programming; device function analysis; data extraction, storage, analysis and/or transfer; and clinical consultation/intervention planning. Depending on the functionality, it can run on dedicated hardware, an off-the-shelf computer (e.g., tablet, smartphone), or web-based servers.
GUDID devices
69
Last updated
2026-07-25 06:05:18

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04035479194192PatientApp 2.10.0BIOTRONIK SE & Co. KG5319972026-07-16
04035479167509Home Monitoring Service CenterBIOTRONIK SE & Co. KG3.472020-01-10
04035479168773Home Monitoring Service CenterBIOTRONIK SE & Co. KG3.482020-05-13
04035479169466Home Monitoring Service CenterBIOTRONIK SE & Co. KG3.492020-09-10
04035479175559Home Monitoring Service CenterBIOTRONIK SE & Co. KG3.512021-10-28
04035479176143Home Monitoring Service CenterBIOTRONIK SE & Co. KG3.502024-09-20
04035479176587Home Monitoring Service CenterBIOTRONIK SE & Co. KG3.532022-01-25
04035479177942Home Monitoring Service CenterBIOTRONIK SE & Co. KG3.542022-06-09
04035479179779Home Monitoring Service CenterBIOTRONIK SE & Co. KG3.552022-10-24
04035479182045Home Monitoring Service CenterBIOTRONIK SE & Co. KG3.572023-05-11
04035479183264Home Monitoring Service CenterBIOTRONIK SE & Co. KG3.582023-10-13
04035479184636Home Monitoring Service CenterBIOTRONIK SE & Co. KG3.592024-01-10
04035479186128Home Monitoring Service CenterBIOTRONIK SE & Co. KG3.602024-05-29
04035479187163Home Monitoring Service CenterBIOTRONIK SE & Co. KG3.612024-09-03
04035479187927SW HMSC 3.62BIOTRONIK SE & Co. KG4918062025-01-20
04035479188689SW HMSC 3.63BIOTRONIK SE & Co. KG4932232025-05-07
04035479189044SW HMSC 3.64BIOTRONIK SE & Co. KG4947062025-10-16
04035479189235SW HMSC 3.65BIOTRONIK SE & Co. KG4966312026-01-20
07640130457300Home Monitoring Service CenterBIOTRONIK SE & Co. KG3.502021-01-14
04035479190538SW HMSC 3.66BIOTRONIK SE & Co. KG4980922026-05-28
04035479189211PatientApp 2.9BIOTRONIK SE & Co. KG4963952026-03-04
05415067049575Merlin™ST. JUDE MEDICAL, INC.MLC10002025-06-25
00802526618208myLUX™ Patient AppBOSTON SCIENTIFIC CORPORATION29292025-04-11
00802526618215myLUX™ Patient AppBOSTON SCIENTIFIC CORPORATION29392025-04-11
00850012625162Guardian Programmer Model PROG-004Avertix Medical Inc.0217-2100-004#P182025-03-05
04035479184445PatientApp 2.8BIOTRONIK SE & Co. KG4844482025-02-12
00802526625404LUX-Dx™BOSTON SCIENTIFIC CORPORATION667256-1102024-09-30
00763000378356Instrument Command LibraryMEDTRONIC, INC.26912024-05-04
00763000378363Device Command LibraryMEDTRONIC, INC.26922024-05-04
00763000754914CareLink SmartSync™ LINQ II™ Insertable Cardiac Monitor (ICM) ApplicationMEDTRONIC, INC.D00U0242024-04-25
00763000891091CareLink SmartSync™ LINQ II™ Platform ApplicationMEDTRONIC, INC.D00U0272024-04-25
00802526621017LUX-Dx™ Clinic Assistant Mobile DeviceBOSTON SCIENTIFIC CORPORATION667256-1002023-12-14
00802526621000myLUX™ Mobile DeviceBOSTON SCIENTIFIC CORPORATION667259-1002023-09-08
00802526621307myLUX™BOSTON SCIENTIFIC CORPORATION666385-1002023-08-31
00802526623103myLUX™ Patient AppBOSTON SCIENTIFIC CORPORATION622939-1202023-08-31
00802526623110myLUX™ Patient AppBOSTON SCIENTIFIC CORPORATION622929-1202023-08-31
04035479183271PatientAppBIOTRONIK SE & Co. KG2.72023-03-30
04035479180461Patient AppBIOTRONIK SE & Co. KG2.52022-09-06
05415067037121Merlin™ST. JUDE MEDICAL, INC.MER34002022-08-29
00763000504519AccuRhythm™ AIMEDTRONIC, INC.ZA4002021-12-31
00763000504526AccuRhythm™ AIMEDTRONIC, INC.ZA4102021-12-31
00763000504533AccuRhythm™ AIMEDTRONIC, INC.ZA4202021-12-31
00850012625063AngelMed Guardian Programmer Model PROG-003Avertix Medical Inc.0204-2100-075#P162021-02-25
00850012625087AngelMed Guardian Programmer Serial Cable, 6 FootAvertix Medical Inc.0204-2100-085#P102021-02-25
00850012625094AngelMed Guardian Programmer Serial Cable, 10 FootAvertix Medical Inc.0204-2100-1122021-02-25
00850012625100AngelMed Guardian Programmer External Power AccessoriesAvertix Medical Inc.0204-2100-093#P102021-02-25
00850012625124AngelMed Guardian Programmer USB Flash DriveAvertix Medical Inc.0204-2100-077#P102021-02-25
00850012625131AngelMed Guardian Programmer Application User's Manual CDAvertix Medical Inc.0204-2100-073#P162021-02-25
00850012625148AngelMed Guardian Programmer PROG-003 Carrying CaseAvertix Medical Inc.0204-2100-079#P102021-02-25
05415067032812myMerlinPulse™ST. JUDE MEDICAL, INC.APP10042021-01-07
05415067032829myMerlinPulse™ST. JUDE MEDICAL, INC.APP10052021-01-07
00763000351656TriageHF™MEDTRONIC, INC.52422020-07-23
00802526607363myLUX™ Patient Kit with mobile deviceBOSTON SCIENTIFIC CORPORATION666259-1002020-07-01
00802526607370LUX-Dx™ Clinic Assistant Kit with mobile deviceBOSTON SCIENTIFIC CORPORATION666256-1002020-07-01
00802526607608myLUX™ patient appBOSTON SCIENTIFIC CORPORATION622925-1002020-07-01
00802526607615LUX-Dx™ Clinic Assistant appBOSTON SCIENTIFIC CORPORATION622935-1002020-07-01
00763000002046CareLink SmartSync™ Percepta Serena Solara ApplicationMEDTRONIC, INC.D00U0042019-07-13
00763000002039CareLink SmartSync™ Azure Astra ApplicationMEDTRONIC, INC.D00U0032019-04-06
00763000017347CareLink® NetworkMEDTRONIC, INC.CLN2017-12-16
00643169545519Reveal LINQ™ Mobile ManagerMEDTRONIC, INC.MSW0012015-11-11
00643169545526CareLink Express™ Mobile SystemMEDTRONIC, INC.313012016-11-25
00643169636651Reveal LINQ™ Mobile ManagerMEDTRONIC, INC.MSW0022016-06-06
00643169636668CareLink Express™ Mobile SystemMEDTRONIC, INC.313022016-11-25
00643169731004CareLink® NetworkMEDTRONIC, INC.CLN072016-04-04
00643169833715CareLink SmartSync™ Common ApplicationMEDTRONIC, INC.M01G022017-05-25
00643169833739CareLink SmartSync™ Common ApplicationMEDTRONIC, INC.M01A022017-05-25
00643169833753CareLink SmartSync™ PSA ApplicationMEDTRONIC, INC.D00U0022017-05-25
00643169878068CareLink® NetworkMEDTRONIC, INC.CLN092016-11-07
00643169878075CareLink® NetworkMEDTRONIC, INC.CLN102017-05-19