Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MO & OTW

Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

FDA Pre-Market Approval

FDA Class 3 ·Optune Lua

Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

FDA Pre-Market Approval

FDA Class 3 ·Optune Lua

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

FDA Pre-Market Approval

FDA Class 3 ·INSYNC MARQUIS/SENTRY/MAXIMO/CONCERTO & VIRTUOSO CRT-ICDS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS PAVEMAKERS, CARELINK MONITOR, CARDIOSIGHT READER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SELECTED FAMILIES OF PACEMAKERS

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ASTRA S DR/ XT DR /SR MRI IPG

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Storz Medical Duolith SD1 Shock Wave Therapy Device

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR, EVERA S VR, EVERA XT DR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR, EVERA S VR, EVERA XT DR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera S DR,VR ICD; Evera XT DR, VR ICD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S DR/SR MRI IPG, and Azure XT DR/SR MRI IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S DR/SR MRI IPG and Azure XT DR/SR MRI IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG and Azure S DR/SR MRI IPG, Azure XT DR/SR MRI IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Azure S DR MR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia, Advisa DR/SR MRI, Astra S DR/SR MRI, Astra XT DR/SR, Attesta DR/SR MRI, Azure S DR/SR MRI, Relia,

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra S DR, S SR MRI IPG, Astra XT DR,SR MRI IPG; Azure S DR,S SR MRI IPG, Azure XT DR,SR MRI IPG.