<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00802526595578</udiDi>
    <basicUdiDi>01915060000000000000083MW</basicUdiDi>
    <tradeName>MOMENTUM™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000010993</manufacturerSrn>
    <authorisedRepresentativeName>Guidant Europe NV/SA; Boston Scientific</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000008410</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01050301</emdnCode>
    <emdnDescription>IMPLANTABLE TRIPLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>G126</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:26.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526595646</udiDi>
    <basicUdiDi>01915060000000000000083MW</basicUdiDi>
    <tradeName>MOMENTUM™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000010993</manufacturerSrn>
    <authorisedRepresentativeName>Guidant Europe NV/SA; Boston Scientific</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000008410</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01050301</emdnCode>
    <emdnDescription>IMPLANTABLE TRIPLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>G138</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:26.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526595653</udiDi>
    <basicUdiDi>01915060000000000000083MW</basicUdiDi>
    <tradeName>VIGILANT™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000010993</manufacturerSrn>
    <authorisedRepresentativeName>Guidant Europe NV/SA; Boston Scientific</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000008410</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01050301</emdnCode>
    <emdnDescription>IMPLANTABLE TRIPLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>G248</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:26.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526595806</udiDi>
    <basicUdiDi>01915060000000000000083MW</basicUdiDi>
    <tradeName>CHARISMA™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000010993</manufacturerSrn>
    <authorisedRepresentativeName>Guidant Europe NV/SA; Boston Scientific</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000008410</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01050301</emdnCode>
    <emdnDescription>IMPLANTABLE TRIPLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>G337</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:26.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526595820</udiDi>
    <basicUdiDi>01915060000000000000083MW</basicUdiDi>
    <tradeName>CHARISMA™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000010993</manufacturerSrn>
    <authorisedRepresentativeName>Guidant Europe NV/SA; Boston Scientific</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000008410</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01050301</emdnCode>
    <emdnDescription>IMPLANTABLE TRIPLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>G347</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:26.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526595837</udiDi>
    <basicUdiDi>01915060000000000000083MW</basicUdiDi>
    <tradeName>RESONATE™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000010993</manufacturerSrn>
    <authorisedRepresentativeName>Guidant Europe NV/SA; Boston Scientific</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000008410</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01050301</emdnCode>
    <emdnDescription>IMPLANTABLE TRIPLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>G428</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:26.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526595844</udiDi>
    <basicUdiDi>01915060000000000000083MW</basicUdiDi>
    <tradeName>RESONATE™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000010993</manufacturerSrn>
    <authorisedRepresentativeName>Guidant Europe NV/SA; Boston Scientific</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000008410</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01050301</emdnCode>
    <emdnDescription>IMPLANTABLE TRIPLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>G447</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:26.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526595851</udiDi>
    <basicUdiDi>01915060000000000000083MW</basicUdiDi>
    <tradeName>RESONATE™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000010993</manufacturerSrn>
    <authorisedRepresentativeName>Guidant Europe NV/SA; Boston Scientific</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000008410</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01050301</emdnCode>
    <emdnDescription>IMPLANTABLE TRIPLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>G448</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:26.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526595868</udiDi>
    <basicUdiDi>01915060000000000000083MW</basicUdiDi>
    <tradeName>RESONATE™ CRT-D</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000010993</manufacturerSrn>
    <authorisedRepresentativeName>Guidant Europe NV/SA; Boston Scientific</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000008410</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01050301</emdnCode>
    <emdnDescription>IMPLANTABLE TRIPLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>G424</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:26.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526595875</udiDi>
    <basicUdiDi>01915060000000000000083MW</basicUdiDi>
    <tradeName>CHARISMA™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000010993</manufacturerSrn>
    <authorisedRepresentativeName>Guidant Europe NV/SA; Boston Scientific</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000008410</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01050301</emdnCode>
    <emdnDescription>IMPLANTABLE TRIPLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>G348</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:26.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526595882</udiDi>
    <basicUdiDi>01915060000000000000083MW</basicUdiDi>
    <tradeName>RESONATE™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000010993</manufacturerSrn>
    <authorisedRepresentativeName>Guidant Europe NV/SA; Boston Scientific</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000008410</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01050301</emdnCode>
    <emdnDescription>IMPLANTABLE TRIPLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>G425</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:26.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526595912</udiDi>
    <basicUdiDi>01915060000000000000083MW</basicUdiDi>
    <tradeName>CHARISMA™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000010993</manufacturerSrn>
    <authorisedRepresentativeName>Guidant Europe NV/SA; Boston Scientific</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000008410</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01050301</emdnCode>
    <emdnDescription>IMPLANTABLE TRIPLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>G328</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:26.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526595929</udiDi>
    <basicUdiDi>01915060000000000000083MW</basicUdiDi>
    <tradeName>RESONATE™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000010993</manufacturerSrn>
    <authorisedRepresentativeName>Guidant Europe NV/SA; Boston Scientific</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000008410</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01050301</emdnCode>
    <emdnDescription>IMPLANTABLE TRIPLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>G426</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:26.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526595936</udiDi>
    <basicUdiDi>01915060000000000000083MW</basicUdiDi>
    <tradeName>CHARISMA™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000010993</manufacturerSrn>
    <authorisedRepresentativeName>Guidant Europe NV/SA; Boston Scientific</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000008410</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01050301</emdnCode>
    <emdnDescription>IMPLANTABLE TRIPLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>G324</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:26.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526595943</udiDi>
    <basicUdiDi>01915060000000000000083MW</basicUdiDi>
    <tradeName>RESONATE™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000010993</manufacturerSrn>
    <authorisedRepresentativeName>Guidant Europe NV/SA; Boston Scientific</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000008410</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>J01050301</emdnCode>
    <emdnDescription>IMPLANTABLE TRIPLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>G437</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:25.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000178116</udiDi>
    <basicUdiDi>B-00763000178116</basicUdiDi>
    <tradeName>Cobalt™ XT HF Quad CRT-D MRI SureScan™</tradeName>
    <deviceName>Cobalt XT, Cobalt, and Crome CRT-D</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J01050301</emdnCode>
    <emdnDescription>IMPLANTABLE TRIPLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTPA2QQ</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-11T03:36:25.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000178321</udiDi>
    <basicUdiDi>B-00763000178321</basicUdiDi>
    <tradeName>Crome™ HF CRT-D MRI SureScan™</tradeName>
    <deviceName>Cobalt XT, Cobalt, and Crome CRT-D</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J01050301</emdnCode>
    <emdnDescription>IMPLANTABLE TRIPLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTPC2D1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:07:13.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000178284</udiDi>
    <basicUdiDi>B-00763000178284</basicUdiDi>
    <tradeName>Crome™ HF Quad CRT-D MRI SureScan™</tradeName>
    <deviceName>Cobalt XT, Cobalt, and Crome CRT-D</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J01050301</emdnCode>
    <emdnDescription>IMPLANTABLE TRIPLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTPC2Q1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-04T22:08:29.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000178277</udiDi>
    <basicUdiDi>B-00763000178277</basicUdiDi>
    <tradeName>Crome™ HF Quad CRT-D MRI SureScan™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>J01050301</emdnCode>
    <emdnDescription>IMPLANTABLE TRIPLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTPC2QQ</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-04T22:08:16.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>00763000178246</udiDi>
    <basicUdiDi>B-00763000178246</basicUdiDi>
    <tradeName>Cobalt™ HF CRT-D MRI SureScan™</tradeName>
    <deviceName>Cobalt XT, Cobalt, and Crome CRT-D</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J01050301</emdnCode>
    <emdnDescription>IMPLANTABLE TRIPLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTPB2D1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-04T22:08:15.274Z</lastUpdated>
  </row>
</eudamedExport>