Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 2490D/E CARELINK MONITORS AND THE SERVER-BASED MODEL 2491 DEVICE DATA MANAGEMENT SOFTWARE APPLICATION (DDMA)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Valiant Thoracic Stent Graft (FreeFlo Tapers Line Extension) with the Captivia Delivery System and Valiant Thoracic Sten

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® QuantiFERON®-TB Gold Plus and LIAISON® XL Control QuantiFERON®-TB Gold Plus

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5 System, Impella CP System, Impella CP Optical System, Impella 5.0 System, and Impella LD System

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·LIAISON XL MUREX HBsAg Qual, LIAISON XL MUREX Control HBsAg Qual and LIAISON XL MUREX HBsAg Confirmatory

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Alinity i Anti-HBs Regent Kit, Alinity i Anti-HBs Calibrators, and Alinity i Anti-HBs Controls

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems of the Evolut R/PRO/PRO+ Systems

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PALTINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIR

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

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LEAD, CONSULTA CRT-P, SYNCRA CRT-P AND VIVA CRT-P

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·Biomet OrthoPak Non-invasive Bone Growth Stimulator System and Biomet SpinalPak Non-invasive Spine Fusion Stimulator Sys

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

FDA Pre-Market Approval

FDA Class 3 ·CapSure SP Novus Lead, CapSure Sp Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 2490D/E CARELINK MONITORS AND THE SERVER-BASED MODEL 2491 DEVICE DATA MANAGEMENT SOFTWARE APPLICATION (DDMA)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LEAD ADAPTOR, IS-1 PORT PIN PLUG, SPRINT, SPRINT FIDELIS, QUATTRO, QUATTRO SECURE & SUBCUTANEOUS DEFIBRILLATION LEADS

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·FLEX34 Active Electrode, Insertion Electrode (IE) FLEX34, Insertion Probe, Insertion Probe L and Auditory Nerve Test Sys

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·AEGEA Vapor System, Aegea Vapor Probe Procedure Kit, Aegea Vapor Generator and Aegea Vapor Generator Accessory Kit

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Blazer II Catheter, Blazer II HTD Catheter, Blazer Prime HTD Catheter, and IntellaNav ST Catheter, Sterile Cables

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate Model 400 Type 1.0 & Type 1.1, Exablate Transcranial MRgFUS, Exablate Neuro, Exablate TcMRgFUS, Exablate Neurav

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

FDA Pre-Market Approval

FDA Class 3 ·CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF ASPHERIC UV-ABSORBING RESTOR +2.5 INRAOCULAR LENS & ACRTSOF ASPHERIC UV-ABSORBING RESTOR +3.0 INTRAOCULAR LENS

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) System, Vercise PC Deep Brain Stimulation (DBS) System, and Vercise Gevia Deep Brai