Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE Z MODELS 5034/5534/5033 PACING LEADS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS MODEL T505 (AORTIC)

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WCD 3000 SYSTEM

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WCD 3000 SYSTEM

Stent, Urethral, Prostatic, Permanent Or Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Paradigm Real-Time Revel Insulin Pump

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 530G Insulin Pump

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion Systems

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·SMARTABLATE SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Guardian Connect System

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·LDR Spine Mobi-C® Cervical Disc Prosthesis

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADARVISION EXCIMER LASER SYSTEM

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·LDR Spine Mobi-C Cervical Disc Prosthesis

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Cerene® Cryotherapy Device

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX AND MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK AV, PRIZM, VITALITY, VITALITY AVT IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD AND RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRIZM 2 VR/DR MODELS 1860/1861, VENTAK PRIZM VR/DR MODELS 1850/1851/1855/

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SELOX SR STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEAD MODELS SR45, SR53, SR60 SR 53,SELOX SR 60

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRIZM 2 VR/DR MODELS 1860/1861; VENTAK PRIZM VR/DR MODELS 1850/1851/1855/1856; VENTAK PRIZM VR/DR HE MODELS 1852