Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) System

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer Muscular VSD Occluder

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LIVIAN/RENEWAL 3/RENEWAL 3RF/RENEWAL 3 AVT PULSE GENERATOR FAMILIES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Accolade Pacemakers

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT(TM)/DVOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK SQ LEAD ARRAY MODEL 0048 AND ENDOTAK SQ LEAD PATCH MODEL 0063

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

FDA Pre-Market Approval

FDA Class 3 ·IntellaNav XP, IntellaNav MiFi XP Ablation Catheters

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT & PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (LATEX-FREE PACKAGING CONFIGURATION ONLY FOR PROVISC)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX, VENTAK MINI FAMILIES OF ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·BIFURCATED BIPOLAR ENDOCARDIAL TINED LEAD/BIPOLAR ENDOCARDIAL LEAD/POSITIVE FIXATION PROTECTED HELIX BIPOLAR ENDOCARDIAL

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

FDA Pre-Market Approval

FDA Class 3 ·Cardiac Resynchronization Therapy Defibrillator (CRT-D) ORIGEN, INOGEN, DYNAGEN, AUTOGEN, PUNCTUA, ENERGEN, INCEPTA, MOM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PRIZM2/VITALITY

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·NG3 FAMILY OF ICD'S (ORIGEN, INOGEN, & DYNAGEN); PROGENY FAMILY OF ICD'S (INCEPTA, ENERGEN, & PUNCTUA)

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·ColoSense®

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

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN CRT-D, ORIGEN X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D, DYNAGEN X4 CRT-D, AUTOGEN CRT-D, MOMENTUM C

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Anneal Parameters

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Blazer II Cardiac Ablation System and Cable

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

FDA Pre-Market Approval

FDA Class 3 ·Maestro™ Ablation Connection Box, IntellaNav™ OI

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer Piccolo Occluder

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MITRACLIP DELIVERY SYSTEM