Aortic Stent

FDA Pre-Market Approval

FDA Class 3 ·CP Stent, Covered CP Stent, Mounted CP Stent, Covered and Mounted CP Stent, Mounted CP Stent, NuDEL

Aortic Stent

FDA Pre-Market Approval

FDA Class 3 ·Minima Stent System

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval

FDA Class 3 ·Dexcom G5 Mobile Continuous Glucose Monitoring System

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM

Aortic Stent

FDA Pre-Market Approval

FDA Class 3 ·G-Armor Stent, G-Armor Covered Stent, G-Armor Mounted Stent, G-Armor Covered Mounted Stent

Aortic Stent

FDA Pre-Market Approval

FDA Class 3 ·Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval

FDA Class 3 ·Simplera (TM) System

Aortic Stent

FDA Pre-Market Approval

FDA Class 3 ·Minima Stent System

Aortic Stent

FDA Pre-Market Approval

FDA Class 3 ·Minima Stent System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II PCD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM,JEWEL,MOCRO JEWEL,JEWEL PLUS,MICRO JEWEL II,PCD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II, PCD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II, PCD

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

FDA Pre-Market Approval

FDA Class 3 ·INTELLANAV STABLEPOINT™ Ablation Catheter & Force Sensing System on the RHYTHMIA HDX™ Mapping System

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACCESSORY (UPSIZING SLEEVE)/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACCESSORY (UPSIZING SLEEVE)/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACCESSORY (UPSIZING SLEEVE)/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN CAP

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer Open-Irrigated and IntellaNav Open-Irrgated Ablation Catheters