Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System, Ascenda Intrathecal Catheters

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·DRUG dELIVERY ACCESSORIES, DRUG DELIVERY CATHETERS, DRUG DELIVERY INFUSION PUMPS SYNCHROMED FAMILY, DRUG DELIVERY KITS F

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL PROGRAMMER SOFTWARE (SW) MODEL 2845 V4.33

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Revo MRI SureScan IPG

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI/Quad, Brava/Quad CRT-D, Claria MRI/Quad CRT-D, Compia MRI/Quad CRT-D, Consulta CRT-D, Maximo II CRT-D, Vivad

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Maestro 4000 Controller Firmware

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra TPS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Maestro 4000 Controller Firmware

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta, Percept Bipolar, Percepta Quadripolar, Serena Bipolar/Quadripolar, Syncra, Viva CRT-P

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera/MRI/DF, ICD, S DR, XT DR, S VR, XT VR, Maximo II ICD, Secura DR ICD/ DR, Visia AF MRI DFI ICD/VR ICD

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Maestro 4000 Controller Firmware

Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

FDA Pre-Market Approval

FDA Class 3 ·remede® System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim Family of Implantable Pulse Generators; St.Jude Medical External Pulse Generator, Clinical Programmer and Patie

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P,Solar Bipolar CRT-P,

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFLENS (POLYMACON) CONTACT LENSES