Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM S-ICD Pulse Generator and EMBLEM MRI S-ICD Pulse Generator

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI

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

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER/FRONTIER II FAMILY OF CRT-PS

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

FDA Pre-Market Approval

FDA Class 3 ·QDOT MICRO™ System

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM

Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. X

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM

Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr., LVIS EVO

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ALTO 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval

FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIRTUOSO/VIRTUOSO II DR/VR ICD/SECURA DR/VR ICD/MAXIMO II DR/VR ICD

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

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO/CONCERTO II CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARELINK MONITOR

System, Imaging, Fluorescence

FDA Pre-Market Approval

FDA Class 3 ·XILLIX-LIFE-LUNG

System, Imaging, Fluorescence

FDA Pre-Market Approval

FDA Class 3 ·PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA

System, Imaging, Fluorescence

FDA Pre-Market Approval

FDA Class 3 ·PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA

System, Imaging, Fluorescence

FDA Pre-Market Approval

FDA Class 3 ·PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA

System, Imaging, Fluorescence

FDA Pre-Market Approval

FDA Class 3 ·ONCO-LIFE ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (ONCO-LIFE)