Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GUIDANT PULSE GENERATORS

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra TPS, Micra AV TPS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Evera MRI Application, CareLink SmartSync Visia AF Application

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Advisa DR MRI IPG, Advisa SR MRI IPG

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BAUSCH & LOMB PUREVISION (BALAFILCON A) SOFT CONTACT LENS

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

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Viva Brava Evera Application, CareLink SmartSync Claria Amplia Compia Application

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·FlexAbility Ablation Catheter (Bi-Directional)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ANTHEM & ANTHEM RF CRT-P'S

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ACCENT DR, ACCENT DR RF, ACCENT SR, ACCENT SR RF PACEMAKERS

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·CERAMAX Ceramic Total Hip System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC ABLATION CATHETER AND SAFIRE BI-DIRECTIONAL ABLATION CATHETER

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System, Ascenda Intratecal Catheters

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Bi-Directional Torque Wrench Model 6628

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

FDA Pre-Market Approval

FDA Class 3 ·Bi-Directional Torque Wrench Model 6628

Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

FDA Pre-Market Approval

FDA Class 3 ·TOP2A FISH PHARMADX KIT

Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

FDA Pre-Market Approval

FDA Class 3 ·TOP2A FISH PHARMDX KIT

Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

FDA Pre-Market Approval

FDA Class 3 ·TOP2A FISH PHARMDX

Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

FDA Pre-Market Approval

FDA Class 3 ·TOP2A FISH PHARMDX KIT