FDA.reportPublic FDA data

Single-chamber implantable pacemaker, rate-responsive

Definition
A sterile, battery-powered device consisting of a hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with a pacing lead in or on one chamber of the heart (right atrium or ventricle). It is intended to generate and conduct electrical impulses to an abnormal heart to adjust its 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 to provide defibrillation therapy.
GUDID devices
65
Last updated
2021-01-19 09:29:22

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00763000316716Azure™ S SR MRI SureScan™MEDTRONIC, INC.W3SR012021-01-08
00763000316778Adapta™MEDTRONIC, INC.ADSR01P2020-11-28
00763000316785Adapta™MEDTRONIC, INC.ADSR032020-11-28
00763000316792Adapta™MEDTRONIC, INC.ADSR062020-11-28
08031527009162EspritMICROPORT CRM SRLSR2014-09-05
08031527012247ReplyMICROPORT CRM SRLSR2014-09-05
00763000316839Attesta™ SR MRI SureScan™MEDTRONIC, INC.ATSR012020-07-30
05414734006224Microny™ST. JUDE MEDICAL, INC.2525T2017-02-07
05414734006774Verity™ST. JUDE MEDICAL, INC.ADx XL SR2017-02-03
H758505608Verity®ST. JUDE MEDICAL, INC.ADx XL SC2014-10-23
H758515609Verity®ST. JUDE MEDICAL, INC.ADx XL SR2014-10-23
H758516004Integrity® ST. JUDE MEDICAL, INC.ADx SR2014-10-25
H758517207Identity® ST. JUDE MEDICAL, INC.SR2014-10-23
H758518006Identity® ST. JUDE MEDICAL, INC.ADx SR2014-10-23
H758561004Victory® ST. JUDE MEDICAL, INC.SR2014-10-23
05414734501712Zephyr™ST. JUDE MEDICAL, INC.XL SR2017-02-03
05414734502740Accent™ST. JUDE MEDICAL, INC.SR2017-04-10
05414734502757Accent™ST. JUDE MEDICAL, INC.SR RF2017-04-10
H758562005Zephyr®ST. JUDE MEDICAL, INC.SR2014-10-23
05414734504737Sustain™ST. JUDE MEDICAL, INC.PM11362017-04-10
05414734504744Sustain™ST. JUDE MEDICAL, INC.PM11342017-04-10
05414734507042Endurity™ST. JUDE MEDICAL, INC.PM11602017-04-10
05414734507066Assurity™ST. JUDE MEDICAL, INC.PM12402017-04-10
05414734507080Assurity™ST. JUDE MEDICAL, INC.PM12602017-04-10
05414734509572Assurity MRI™ST. JUDE MEDICAL, INC.PM12722017-02-07
05414734509596ENDURITY MRI™ST. JUDE MEDICAL, INC.SSIR2017-02-07
00763000059620Advisa SR MRI™ SureScan®MEDTRONIC, INC.A3SR012017-10-20
00802526484384ALTRUA™ 20BOSTON SCIENTIFIC CORPORATIONS2012014-09-24
00802526484438ALTRUA™ 40BOSTON SCIENTIFIC CORPORATIONS4012014-09-24
00802526484469ALTRUA™ 60BOSTON SCIENTIFIC CORPORATIONS6012014-09-24
00802526499128ALTRUA™ 20BOSTON SCIENTIFIC CORPORATIONS2042014-09-24
00802526516658ADVANTIO™BOSTON SCIENTIFIC CORPORATIONK0622014-09-24
00802526516818INGENIO™BOSTON SCIENTIFIC CORPORATIONK1722014-09-24
00802526516955VITALIO™BOSTON SCIENTIFIC CORPORATIONK2722014-09-24
00802526516962VITALIO™BOSTON SCIENTIFIC CORPORATIONK2732014-09-24
00802526536557VITALIO™BOSTON SCIENTIFIC CORPORATIONK2742014-09-24
00802526558900ESSENTIO™ SRBOSTON SCIENTIFIC CORPORATIONL1002014-11-11
00802526558948ESSENTIO™ MRI SRBOSTON SCIENTIFIC CORPORATIONL1102016-05-10
00802526559020PROPONENT™ SRBOSTON SCIENTIFIC CORPORATIONL2002014-11-11
00802526559150ACCOLADE™ SRBOSTON SCIENTIFIC CORPORATIONL3002014-11-11
00802526559204ACCOLADE™ MRI SRBOSTON SCIENTIFIC CORPORATIONL3102016-05-10
00802526559327ALTRUA™ 2 SRBOSTON SCIENTIFIC CORPORATIONS7012014-11-11
00643169402669Advisa SR MRI™ SureScan™MEDTRONIC, INC.A3SR012015-04-21
00643169474208Adapta®MEDTRONIC, INC.ADSR012015-02-04
00643169474215Adapta®MEDTRONIC, INC.ADSR01P2015-02-10
00643169474222Adapta®MEDTRONIC, INC.ADSR032015-02-05
00643169474260Sensia®MEDTRONIC, INC.SESR012015-02-05
00643169634626Azure™ XT SR MRI SureScan™MEDTRONIC, INC.W1SR012017-12-02
00643169634640Azure™ S SR MRI SureScan™MEDTRONIC, INC.W3SR012017-12-02
00643169708808Adapta™MEDTRONIC, INC.ADSR012017-06-24
00643169708815Adapta™MEDTRONIC, INC.ADSR01P2017-06-24
00643169708846Adapta™MEDTRONIC, INC.ADSR032017-06-24
00643169708860Adapta™MEDTRONIC, INC.ADSR062017-06-24
00643169708945Sensia™MEDTRONIC, INC.SESR012017-06-24
00643169709041Adapta™MEDTRONIC, INC.ADSR012017-10-20
00643169709065Sensia™MEDTRONIC, INC.SESR012017-10-20
00643169871953Azure™ XT SR MRI SureScan™MEDTRONIC, INC.W1SR012017-11-02
00643169871977Azure™ S SR MRI SureScan™MEDTRONIC, INC.W3SR012017-11-02
00613994222152Adapta™MEDTRONIC, INC.ADSR012014-09-23
00613994222169Adapta™MEDTRONIC, INC.ADSR01P2014-09-23
00613994222176Adapta™MEDTRONIC, INC.ADSR032014-09-23
00613994222190Adapta™MEDTRONIC, INC.ADSR062014-09-23
00613994223807Sensia™MEDTRONIC, INC.SESR012014-09-23
00613994763259Adapta™MEDTRONIC, INC.ADSR012014-09-23
00613994763327Sensia™MEDTRONIC, INC.SESR012014-09-23