Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI II COOLED ABLATION CATHETER AND CABLE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II XP CARDIAC ABLATION CATHETER/CABLE/BLAZER II HIGH TORQUE DISTAL (HTD) ABLATION CATHETER/CABLE/BLAZER PRIME

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VITESSE XTO 0.9 MM CORONARY ANGIOPLASTY CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR RMT THERMOCOOL MAGNETIC STEERING CATHETERS

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CVX-300 EXCIMER LASER SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER, SAFIRE BI-DIRECTIONAL ABLATION CATHETER

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ELCA CORONARY ATHERECTOMY CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI COOLED ABLATION SYSTEM

Implanted Fecal Incontinence Device

FDA Pre-Market Approval

FDA Class 3 ·AMS ACTICON NEOSPHINCTER-ARTIFICIAL BOWL SPHINCTER (ABS)

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS)

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

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC CONCERTO MODEL C154DWK ICD

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL P1501DR ENRHYTHM IMPLANTABLE PULSE GENERATOR, MEDTRONIC MODEL 9987 APPLICATION SOFTWARE AND MEDTRONIC MO

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

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-D & MAXIMO II CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SECURA DR & MAXIMO II DR & SECURA VR & MAXIMO II VR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC AT500 DDDRP PACING SYSTEM (MODEL AT501) AND MODEL 9968 SOFTWARE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC 2490C CARELINK MONITOR 2020A CARDIOSIGHT READER

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

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO/CONCERTO II; CONSULTA; MAXIMO II; AND PROTECTA/PROTECTA XT