FDA.reportPublic FDA data

Dual-chamber implantable pacemaker, rate-responsive

Definition
A sterile, battery-powered, hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with pacing leads in or on two chambers of the heart (right atrium and ventricle). It is intended to stimulate the chambers of an abnormal heart, through electrical impulses, to beat in their natural sequence, and to adjust the rate of contraction to meet the body's increased need for blood flow due to activity. It contains one or more sensors to detect changes in the body (e.g., motion, breathing frequency) to indicate more oxygen is needed, and subsequently increases the pacing rate; it is not intended for defibrillation therapy.
GUDID devices
106
Last updated
2021-01-19 09:29:22

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00763000316693Azure™ S DR MRI SureScan™MEDTRONIC, INC.W3DR012021-01-08
00763000316846Azure™ XT DR MRI SureScan™MEDTRONIC, INC.W1DR012021-01-08
00763000316723Adapta™MEDTRONIC, INC.ADDR032020-11-28
00763000316730Adapta™MEDTRONIC, INC.ADDR062020-11-28
00763000316747Adapta™ SMEDTRONIC, INC.ADDRS1P2020-11-28
00763000316761Adapta™MEDTRONIC, INC.ADVDD012020-11-28
08031527009056EspritMICROPORT CRM SRLDR2014-09-05
08031527011523ReplyMICROPORT CRM SRLDR2014-09-05
00763000316808Attesta™ DR MRI SureScan™MEDTRONIC, INC.ATDR012020-07-30
00763000316815Attesta™ L DR MRI SureScan™MEDTRONIC, INC.ATDRL12020-07-30
00763000316822Attesta™ S DR MRI SureScan™MEDTRONIC, INC.ATDRS12020-07-30
05414734006811Verity™ST. JUDE MEDICAL, INC.ADx XL DC2017-02-03
05414734006828Identity™ST. JUDE MEDICAL, INC.52862017-01-25
05414734006835Verity™ST. JUDE MEDICAL, INC.ADx XL DR2017-02-03
05414734006842Verity™ST. JUDE MEDICAL, INC.ADx XL DR2017-02-03
05414734006866Integrity™ST. JUDE MEDICAL, INC.ADx XL DR2017-02-03
05414734006880Identity™ST. JUDE MEDICAL, INC.53762017-02-06
05414734006903Identity™ST. JUDE MEDICAL, INC.53862017-01-25
05414734006910Verity™ST. JUDE MEDICAL, INC.ADx XL VDR2017-02-03
H758536006Integrity® ST. JUDE MEDICAL, INC.ADx DR2014-10-25
H758537007Identity® ST. JUDE MEDICAL, INC.DR2014-10-23
H758538008Identity®ST. JUDE MEDICAL, INC.ADx DR2014-10-23
H758548009Identity® ST. JUDE MEDICAL, INC.ADx VDR2014-10-29
05414734009553Victory™ST. JUDE MEDICAL, INC.58162017-02-03
05414734010474Verity™ST. JUDE MEDICAL, INC.ADx XL VDR2017-02-03
H758581006Victory® ST. JUDE MEDICAL, INC.DR2014-10-23
05414734501620Zephyr™ST. JUDE MEDICAL, INC.XL DR2017-02-03
05414734503600Accent™ST. JUDE MEDICAL, INC.DR2017-04-10
05414734504713Sustain™ST. JUDE MEDICAL, INC.PM21362017-04-10
H758582007Zephyr®ST. JUDE MEDICAL, INC.DR2014-10-23
H758PM221001Accent®ST. JUDE MEDICAL, INC.DR RF2014-10-23
05414734504720Sustain™ST. JUDE MEDICAL, INC.PM21342017-04-10
05414734507059Endurity™ST. JUDE MEDICAL, INC.PM21602017-04-10
05414734507073Assurity™ST. JUDE MEDICAL, INC.PM22402017-04-10
05414734507097Assurity™ST. JUDE MEDICAL, INC.PM22602017-04-10
05414734509589Assurity MRI™ST. JUDE MEDICAL, INC.PM22722017-02-07
05414734509602ENDURITY MRI™ST. JUDE MEDICAL, INC.DDDR2017-02-07
00763000059613Advisa DR MRI™ SureScan®MEDTRONIC, INC.A2DR012017-10-20
00802526484391ALTRUA™ 20BOSTON SCIENTIFIC CORPORATIONS2032014-09-24
00802526484421ALTRUA™ 20BOSTON SCIENTIFIC CORPORATIONS2082014-09-24
00802526484445ALTRUA™ 40BOSTON SCIENTIFIC CORPORATIONS4032014-09-24
00802526484452ALTRUA™ 40BOSTON SCIENTIFIC CORPORATIONS4042014-09-24
00802526484476ALTRUA™ 60BOSTON SCIENTIFIC CORPORATIONS6022014-09-24
00802526484483ALTRUA™ 60BOSTON SCIENTIFIC CORPORATIONS6032014-09-24
00802526484490ALTRUA™ 60BOSTON SCIENTIFIC CORPORATIONS6062014-09-24
00802526499210ALTRUA™ 20BOSTON SCIENTIFIC CORPORATIONS2052014-09-24
00802526516702ADVANTIO™BOSTON SCIENTIFIC CORPORATIONK0632014-09-24
00802526516719ADVANTIO™BOSTON SCIENTIFIC CORPORATIONK0642014-09-24
00802526516825INGENIO™BOSTON SCIENTIFIC CORPORATIONK1732014-09-24
00802526517259FORMIO™BOSTON SCIENTIFIC CORPORATIONK2782014-09-24
00802526536786INGENIO™BOSTON SCIENTIFIC CORPORATIONK1742014-09-24
00802526558924ESSENTIO™ DRBOSTON SCIENTIFIC CORPORATIONL1012014-11-11
00802526558962ESSENTIO™ MRI DRBOSTON SCIENTIFIC CORPORATIONL1112016-05-10
00802526558986ESSENTIO™ EL DRBOSTON SCIENTIFIC CORPORATIONL1212014-11-11
00802526559006ESSENTIO™ MRI EL DRBOSTON SCIENTIFIC CORPORATIONL1312016-05-10
00802526559044PROPONENT™ DRBOSTON SCIENTIFIC CORPORATIONL2012014-11-11
00802526559112PROPONENT™ EL DRBOSTON SCIENTIFIC CORPORATIONL2212014-11-11
00802526559174ACCOLADE™ DRBOSTON SCIENTIFIC CORPORATIONL3012014-11-11
00802526559228ACCOLADE™ MRI DRBOSTON SCIENTIFIC CORPORATIONL3112016-05-10
00802526559242ACCOLADE™ EL DRBOSTON SCIENTIFIC CORPORATIONL3212014-11-11
00802526559266ACCOLADE™ MRI EL DRBOSTON SCIENTIFIC CORPORATIONL3312016-05-10
00802526559341ALTRUA™ 2 DRBOSTON SCIENTIFIC CORPORATIONS7022014-11-11
00802526559365ALTRUA™ 2 EL DRBOSTON SCIENTIFIC CORPORATIONS7222014-11-11
00643169441873Adapta®MEDTRONIC, INC.ADDR012014-09-29
00643169474154Adapta®MEDTRONIC, INC.ADDR032015-02-05
00643169474161Adapta®MEDTRONIC, INC.ADDR062015-02-05
00643169474178Adapta® LMEDTRONIC, INC.ADDRL12015-02-05
00643169474192Adapta® SMEDTRONIC, INC.ADDRS12015-02-05
00643169474246Adapta®MEDTRONIC, INC.ADVDD012015-02-05
00643169474253Sensia®MEDTRONIC, INC.SEDR012015-02-05
00643169474277Versa®MEDTRONIC, INC.VEDR012015-02-05
00643169493377Advisa DR MRI™ SureScan®MEDTRONIC, INC.A2DR012015-02-05
00643169493407Revo MRI™ SureScan™MEDTRONIC, INC.RVDR012015-02-05
00643169634589Azure™ XT DR MRI SureScan™MEDTRONIC, INC.W1DR012017-12-02
00643169634602Azure™ S DR MRI SureScan™MEDTRONIC, INC.W3DR012017-12-02
00643169708600Adapta™MEDTRONIC, INC.ADDR012017-10-20
00643169708624Adapta™MEDTRONIC, INC.ADDR012017-06-24
00643169708648Adapta™MEDTRONIC, INC.ADDR032017-06-24
00643169708662Adapta™MEDTRONIC, INC.ADDR062017-06-24
00643169708686Adapta™ LMEDTRONIC, INC.ADDRL12017-10-20