Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·END CAP, UPSIZING SLEEVE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera RI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mi

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Visia AF App, CareLink SmartSync Evera MRI App, CareLink SmartSync Viva Consulta Syncra Advisa Ensura

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 VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD,

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI, S DR, S VR, XT DR, XT VR ICD'S; Maximo Ii ICD; Protecta ICD, XT ICD; Secura DR ICD, Secura ICD; Virtuoso II D

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MYCARELINK PATIENT MONITOR, MYCARELINK READER FIELD REPLACEMENT UNIT (FRU), MYCARELINK SMART PATIENT READER, CARELINK EN

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SYMBIOS MODEL 7006 & SYNERGYST MODEL 7026 PULSE G.

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SELECT SECURE LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 9710E ENHEANCED PROGRAMMING SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST, INTRINSIC, MARQUIS, ONYX, SECURA, & VARIOUS FAMILIES/MODELS OF GEM, MAXIMO, PROTECTA, & VIRTUOSO

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST ICDS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE Z NOVUS, CAPSURE SP NOVUS, CAPSURE SP Z, CAPSURE Z NOVUS, & IMPULSE II LEADS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix Novus Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·BRAVA CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D VIVA S CRT-D, VIVA XT CRT-D

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE(R)SP MODELS 4024/4524 PACING LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 5388 EXTERNAL PULSE GENERATOR