<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00802526593932</udiDi>
    <basicUdiDi>01915060000000000000084MY</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>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>D233</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:27.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526593949</udiDi>
    <basicUdiDi>01915060000000000000084MY</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>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>D333</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:27.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526593956</udiDi>
    <basicUdiDi>01915060000000000000084MY</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>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>D220</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:27.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526593963</udiDi>
    <basicUdiDi>01915060000000000000084MY</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>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>D232</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:27.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526593970</udiDi>
    <basicUdiDi>01915060000000000000084MY</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>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>D421</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:27.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526593987</udiDi>
    <basicUdiDi>01915060000000000000084MY</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>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>D321</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:27.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526593994</udiDi>
    <basicUdiDi>01915060000000000000084MY</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>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>D320</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:27.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526594007</udiDi>
    <basicUdiDi>01915060000000000000084MY</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>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>D420</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:27.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526594014</udiDi>
    <basicUdiDi>01915060000000000000084MY</basicUdiDi>
    <tradeName>PERCIVA™</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>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>D400</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:27.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526594021</udiDi>
    <basicUdiDi>01915060000000000000084MY</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>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>D432</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:27.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526594038</udiDi>
    <basicUdiDi>01915060000000000000084MY</basicUdiDi>
    <tradeName>PERCIVA™</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>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>D413</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:27.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526594045</udiDi>
    <basicUdiDi>01915060000000000000084MY</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>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>D332</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:27.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526594052</udiDi>
    <basicUdiDi>01915060000000000000084MY</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>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>D220</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:27.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526594069</udiDi>
    <basicUdiDi>01915060000000000000084MY</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>J01050101</emdnCode>
    <emdnDescription>IMPLANTABLE SINGLE CHAMBER DEFIBRILLATORS, WITH SENSORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>D433</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:26.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526595196</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>G325</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:26.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526595288</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>G237</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:26.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526595295</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>G225</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:26.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526595318</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>G125</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:26.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526595325</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>G228</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:26.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>00802526595349</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>G124</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T12:18:26.687Z</lastUpdated>
  </row>
</eudamedExport>