Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-1

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-1

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-1

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-1

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-1

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Y ADAPTOR/EXTENDER KIT/DF-1 CONNECTOR PORT PIN PLUG/ LEAD ADAPTOR/SPRINT/SPRINT QUATTRO/QUATTRO LEAD/SUBCUTANEOUS LEAD

DEX SURGICAL

System producer

🇫🇷 France

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 6996 SQ LEAD SYSTEM AND 6996T TUNNELING TOOL

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·DF-1 CONNECTOR PORT PIN PLUG/IS-1 CONNECTOR PORT PIN PLUG KIT/SPRINT QUATTRO/SUBCUTANEOUS/TRANSVENCE CS/SVC LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DF-1 CONNECTOR PORT PIN PLUG, IS-1 CONNECTOR PORT PIN PLUG KIT, SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE SVC

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, Lead Adaptor, Sprint Quattro Lead, Subcut

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD DVMB1D1, DDMB1D1, DDMC3D1, DVMC3D1; Evera MRI ICD DDMC3D4, DVMB1D4, DVMC3D4, DDMB1D4; Evera S DR ICD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG KIT, LEAD ADAPTOR, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD, TUNNEL

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Y Adaptor/Extender Kit/DF-1 Connector Port Pin Plug/HV splitter/adaptor kit/Lead Adaptor/Sprint Quattro Lead/Subcutaneou

HX 2028254-1

Certificate

IVDR QMS·DFI Co.,Ltd.·TÜV Rheinland LGA Products GmbH

170726773

Certificate

MDD Annex II (excluding section 4)·Pro-Dex, Inc.·DQS Medizinprodukte GmbH·8 Basic UDI-DIs

059786 MR2 170726773

Certificate

MDD Annex II (excluding section 4)·Pro-Dex, Inc.·DQS Medizinprodukte GmbH·5 Basic UDI-DIs

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LEAD ADAPTOR/IS-1 CONNECTOR PORT PIN PLUG KIT/Y ADAPTOR/EXTENDER KIT/SPRINT LEAD DRUG COMBINATION/TRANSVENE DF1/RV LEAD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·DF-1 Connector Port Pin Plug, IS-1 COnnector Port Pin Plug Kit, Springt Quattro Lead, Subcutaneous Lead, and Transvene C