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

FDA Pre-Market Approval

FDA Class 3 ·IntellaTip MiFi Filter Module, IntellaTip MiFi Reference Cable, EGM Cable, Maestro 4000 Footswitch

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA, SENSIA, ENPULSE E1/E2. KAPPA D/DR/VDD IPG'S

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODELS 2490H CARELINK REMOTE HOME MONITOR, 2020C CARELINK EXPRESS MONITOR, AND 2491 DDMA

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI COOLED RF ABLATION SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC ABLATION CATHETER (NON-IRRIGATED),SAFIRE ABLATION CATHETER (NON-IRRIGATED)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH DUO CATHETER (12 HOLE IRRIGATED), SAFIRE BLU DUO CATHETER(12 HOLE IRRIGATED), COOL PATH DUO ABLATION C

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH CATHETER(6 HOLE IRRIGATED) AND BI-DIRECTIONAL, SAFIRE BLU (6HOLE IRRIGATED) SAFIRE BLUE SP AND THERAPY

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8 CATHETER (NON-IRRIGATED), THERAPY 8MM THERMISTOR ABLATION CATHERER (NON-IRRIGATED) SAFIRE TX CATHETER (NO

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY CATHETER (NON-IRRIGATED)

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval

FDA Class 3 ·FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation C

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

FDA Pre-Market Approval

FDA Class 3 ·BLAZER™ Solid-Tip Ablation Catheter Cable 10’, BLAZER™ Solid-Tip Ablation Catheter Cable 3’, INTELLATIP MIFI™ XP Cable,

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

FDA Pre-Market Approval

FDA Class 3 ·BLAZER™ OI Catheter Cable, INTELLATIP MIFI™ OI Cable, INTELLANAV™ Ablation Catheter Cable

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER™ Solid-Tip Ablation Catheter Cable 10’, BLAZER™ Solid-Tip Ablation Catheter Cable 3’, INTELLANAV™ Ablation Cathet

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAXIMO II/SECURA/VIRTUOSO II

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

FDA Pre-Market Approval

FDA Class 3 ·DiamondTemp Ablation System

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval

FDA Class 3 ·FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable,

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM & GEM II VR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM III DR 7275, GEM III VR 7231, GEM DR 7271

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·G5 Mobile Continuous Glucose Monitoring System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 7276