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

FDA Pre-Market Approval

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-l ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH DUO CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC ABLATION CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8 CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Chilli II Cooled RF Ablation System

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer IITM XP Cardiac RF Ablation System (also branded as Blazer II Prime XP, IntellaTip MiFi XP, IntellaTip MiFi OI, I

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Blazer II Cardiac Ablation System

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer Open Irrigated Cardiac Ablation System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·SmartAblate™ Irrigation Tubing Set

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

FDA Pre-Market Approval

FDA Class 3 ·QUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD

PELLETHANE 75D

FDA 510(k)

FDA Class 3 ·Cardiovascular

OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)

FDA 510(k)

FDA Class 3 ·Cardiovascular

CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER

FDA 510(k)

FDA Class 3 ·Cardiovascular

TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES

FDA 510(k)

FDA Class 3 ·Cardiovascular

CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER

FDA 510(k)

FDA Class 3 ·Cardiovascular

ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)

FDA 510(k)

FDA Class 3 ·Cardiovascular

REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular