Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·E P TECH CARDIAC ABLATION SYSTEM

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval

FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL/VITALITY/LIVIAN/COGNIS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK AV AND VENTAK PRIZM DR/VR AICDS

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

FDA Pre-Market Approval

FDA Class 3 ·VALITUDE / VALITUDE X4 / VISIONIST / VISIONIST X4

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EPT-1000 CARDIAC ABLATION SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·INTELLATIP MIFI OPEN-IRRIGATED ABLATION CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·CHILLI II COOLED ABLATION SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA SINGLE-PEICE POSTERIOR CHAMBER INTRAOCULAR LENSES

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SELUTE LEAD FAMILY

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

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II XP, BLAZER PRIME XP, INTELLA TIP MIFI XP TEMPERATURE ABLATION CATHETERS

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PG ESSENTIO SR, PG ESSENTIO DR, PG PROPONENT SR, PG PROPONENT DR, PG ACCOLADE SR, PG ACCOLADE DR, PG ALTRUA 2 SR, PG ALT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer II XP Cardiac Ablation Catheter and Cable

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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

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 and PERC