Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTWARE VENTRICULAR ASSIST SYSTEM

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DURASPHERE EXP

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia Quad CRT-D; Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MRI

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SCS NEUROSTIMULATORS IMPLANTABLE RESTORE FAMILY

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Medtronic MiniMed iPro2 CGM System with Enlite Sensor

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER)

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·Medtronic MiniMed 630G System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Medtronic MiniMed Paradigm Real-Time Revel System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·Medtronic MiniMed 530G System

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·LINX REFLUX MANAGEMENT SYSTEM

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·Medtronic MiniMed 670G System

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

FDA Pre-Market Approval

FDA Class 3 ·STELID II/STELIX/STELIX II ENDOCARDIAL PACING LEAD

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FOCUS NIGHT & DAY (LOTRAFILCON A) EXTENDED WEAR SOFT CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FOCUS NIGHT AND DAY (LOTRAFILCON A AND B) EXTENDED WEAR SOFT CONTACT LENSES

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·EXCOR® Pediatric Ventricular Assist Device

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Orsiro Sirolimus Eluting Coronary Stent System

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ACTROS SLR+,KAIROS SL PULSE GENERATORS;SL 60-11,13,15 BP SINGLE PASS PACING LEAD;SWM 1000 B-G01.0.U

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)