Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·R Series MCU 20.01 software release

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MULTIPLE APPLICATION UTILITY (MAU) USED WITH ZOOM LATITIDE PROGRAMMING SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX AICD SYSTEM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·ZOLL R Series

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Multiple Application Utility (MAU) and Data Management System (DM) LATITUDE Programming System )LPS)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX AICD SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK MINI AICD SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIGOR MODEL 2880 SOFTWARE APPLICATION

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Implantable Pulse Generators (IPG) Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG; Azu

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·NOVOSTE(TM) BETA-CATH(TM) SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·BETA-CATH (TM) SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·NOVOSTE TM BETA-CATH TM SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·NOVOSTE BETA-CATH SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·GALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·GALILEO(TM) INTRAVASCULAR RADIOTHERAPY SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM