Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Protégé GPS and Protégé RX Carotid Stent Systems, and Protégé GPS Peripheral Stent Systems

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·ISPAN SULFUR HEXAFLUORIDE SF6 GAS

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·ISPAN TM PERFLUOROPROPANE (C3F8)GAS

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LifeVest Wearable Defibrillator

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF MULTIFOCAL POSTERIOR CHAMBER INTRAOCULAR LENSES

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, Mirro MRI DR ICD, M

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF MONFOCAL & ACRYSOF TORIC POSTERIOR CHMABER INTRAOCULAR LENSES & ACRYSERT DELIVERY SYSTEM

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, Compia

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA SINGLE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA MULTI-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

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

FDA Pre-Market Approval

FDA Class 3 ·Tendril SDX Lead, Tendril ST Lead, OptiSense, Tendril STS Lead

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

FDA Pre-Market Approval

FDA Class 3 ·Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex u, Quartet, Quartet CRT Leads

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

FDA Pre-Market Approval

FDA Class 3 ·IsoFlex Optim

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Quartet, Victory, Zephyr, Accent, Assurity, Assurity+Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL D

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Allure, Allure Quadra, Quadra Allure MP

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Microny

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Durata, Optisure