Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Visi-Pro™ Balloon-expandable Peripheral Stent System

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Myopore® Sutureless Myocardial Pacing Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DYNAGEN, INOGEN, ORIGEN

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWWAL TR INVIVE FAMILIES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ICD Devices TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO LEAD

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH(R) INTRASPINAL IMPLANTABLE ACCESS SYST

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CSS-SVC TRANSVENE LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/SECURA/VIRTUOSO/VIRTUOSO II ICDS

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD, CONTAK CD 2, EASYTRAK, CONTAK RENEWAL, CONTAK RENEWAL 3

Agent, Occluding, Vascular, Permanent

FDA Pre-Market Approval

FDA Class 3 ·VENASEAL CLOSURE SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX MRI LEAD

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VERIFLEX MONORAIN & OVER-THE-WIRE CORONARY STENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR MAX CARDIAC CRYOABLATION CATHETER, AROTIC FRONT/AROTIC FRONT ADVANCE /AROTIC FRONT ADVANCE ST CARDIAC CRYOABLATI

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRTD DTMB1D4, DTMB1D1; Amplia MRI Quad CRT-D DTMB1QQ, DTMB1Q1; Brava CRT-D DTBC1D4, DTBC1D1, Brava Quad CRTD

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

FDA Pre-Market Approval

FDA Class 3 ·SMART-MSP

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT (VENOUS) ENDOPROSTHESIS UNISTEP PLUS DELIVERY SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PUNCTUA ICD, TELIGEN ICD, ENERGEN ICD, INCEPTA ICD

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA SC, ACTIVA SC, KINETRA, SOLETRA