Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·REGENCY SC+, REGENCY SC, REGENCY SCX

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PARAGON, PHOENIX, MULTILOG & SENSORITHM PACEMAKERS

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

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-P'S

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX INJECTABLE GEL

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G5 MOBILE CONTIUOUS GLUCOSE MONITORING SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 630G System with SmartGuard

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·iPro2 Continuous Glucose Monitoring (CGM) System with Enlite Sensor

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM AND GUARDIAN REAL-TIME CGM SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PHOTON MICRO, EPIC, ATLAS, EPIC+, AND ATLAS+ FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS PC-58NBM & PC-58NBZ IOLS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER and THERMOCOOL SMARTTOUCH

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Navigation Balloon Kit

Agent, Injectable, Embolic

FDA Pre-Market Approval

FDA Class 3 ·Onyx Liquid Embolic System and Apollo Onyx Delivery Micro Catheter

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Flow Re-Direction Endoluminal Device (FRED) System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System