Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE IS-1/DF-1,RELIANCE 4-SITE PASSIVE FIXATION LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA MRI DF-1/ DF-1 ICD/MRI ICD/ EVERA XT DR ICD/ VR ICD; PROTECTA XT ICD; SECURA ICD; VIRTUOSO II DR/VR ICD; VISIA AF

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR/ S VR/ XT DR/ XT VR ICD's ; Maximo II ICD; Pritectai I

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Viva Quad XT CRTD, Viva XT CRT-D, Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI DF-1 I

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1, Evera MRI, Evera S DR, Evera S VR, Evera XT DR, Evera XT VR, Visia AF MRI DF1, Visia AF MRI VR, Visia AF

RFX+Care International A/S

Authorized representative

🇩🇰 Denmark·2 Manufacturers·646 Devices

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE IS-1/DF-1 LEAD FAMILY,RELIANCE 4-SITE LEAD FAMILY

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278560049·Software Pristina 8.1 - ISO file

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278009289·

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00840682145862·

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00840682142373·

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278711229·UDI Software Pristina

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00840682143516·

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00840682146845·Software Pristina Infinity

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278655141·Software Pristina 8.2 - ISO file

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278795724·Software Pristina 8.3 - ISO file

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278716026·UDI Software Pristina ME 9.1

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD; Visia AF MRI DF1 IC

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Visia AF MRI DF1 IC

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Visia AF MRI DF1 IC