Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEMNOS (TM) CARDIAC PACEMAKER

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEMINI(R) THETA MODEL 415A CARDIAC PACER

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, and PG ACCOLADE MR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ALTRUA 2, ESSENTIO, PROPONENT AND ACCOLADE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AURORA MODELS 6291 & 6292 MULTIPROGRAM. DDD P. GEN

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PACESETTER MODEL 3070 & PACE MEDICAL MODEL 4553

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Biplar CRT-P, Serena Quadripolar CRT-P, Solar

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN OTW/BIPOLAR OTW/CS/LV LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK VITALITY AVT AICD, MODELS A135 AND A155, MODEL 2920 PROGRAMMER WITH MODEL 2812 APPLICATION SOFTWARE VERSION 1.2

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC III

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta/ Serena / Solara Bipolar, Quadripolar CRT-P

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI, Tendril MRI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DISCOVERY, MERIDIAN

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL/VITALITY

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RENEWAL 3 RF CRT-D, MODELS H210, H215, H217 AND H219

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL RF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL 3&4 FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES