Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ingevity Lead Family

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System, and MitraClip G4 Clip Delivery System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DYNAGEN EL, INOGEN EL, ORIGEN EL ICDS

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ACUITY STEERABLE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Blazer II Catheter, Blazer II HTD Catheter, Blazer Prime HTD Catheter, and IntellaNav ST Catheter, Sterile Cables

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER PRIME HTD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK(R) PRX (TM) II AICD SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CYBERLITH IV UNIPOLAR PULSE GENERATOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRIZM 2 FAMILIES, ICD

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

FDA Pre-Market Approval

FDA Class 3 ·ACUITY X4 Straight 86CM ,95CM, ACUITY X4 Spiral S 86CM, 95CM, ACUITY X4 Spiral L 86CM, L95CM, Accessory Suture Sleeves S

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ANTERIOR CHAMBER INTRAOCULAR LENS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·S-ICD GEN and S-ICD EMBLEM MRI

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·DARDIK BIOGRAFT(R) MOD. HUMAN UMBILICAL VEIN GRAFT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATTITUDE PATIENT MANAGEMENT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIGOR MODEL 2880 SOFTWARE APPLICATION

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK(R) PRX(R) AICD(TM) SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIGOR MODEL 2880 SOFTWARE APPLICATION

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK LEAD SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COSMOS(TM) SYSTEM