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

FDA Pre-Market Approval

FDA Class 3 ·DiamondTemp Ablation System

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·Lacrosse NSE ALPHA Coronary Dilatation Catheter

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·Lacrosse NSE ALPHA Coronary Dilatation Catheter

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR(R)

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Anthem PM3210 NKE; Allure, Allure Quadra PM3120, PM3222, PM3140, PM3242; Quadra Allure MP PM3160, PM3262;

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Current, Current Accel, Current+, Ellipse, Fortify, Fortify, Assura, Epic/Epic+, Atlas/II/+, Avant, Gallant, Entrant, Ne

IMPLANTABLE PULSE DEVICES

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 5866-24 PACEMAKER LEAD ADAPTOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

INFANT/CHILD REDUCED ENERGY ELECTRODES

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFEPAK 12 BIPHASIC

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 5013 TRANSVENOUS VENTRICULAR PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFIED MODELS 8320/8322/8329/8316/8317/8318

FDA 510(k)

FDA Class 3 ·Cardiovascular

MINIX, MINIX ST, NEW IC: L74

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFEPAK 20 DEFIBRILLATOR/ MONITOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFEPAK 15 MONITOR/DEFIBRILLATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular