Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·OVATIO VR/DR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY SR 2250, SYMPHONY DR 2550, RHAPSODY SR 2210, RHAPSODY DR 2510, RHAPSODY DR 2530, REPLY ST & REPLY DR PACEMAKERS

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

FDA Pre-Market Approval

FDA Class 3 ·OVATIO CRT

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL Absorbable Hemostat

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·Envision Mammography Platform

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Senza HFX iQ System, Senza HFX iQ IPG, HFX Trial Stimulator, HFX iQ Remote, HFX iQ Patient Application

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX Endovascular AAA System (AFX System)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX ENDOVASCULAR AAA SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX ENDOVASCULAR AAA SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·HFX App

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·INTEGRITY AFX DR (MODEL 5342) & SR (MODEL 5142) PULSE GENERATORS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX2 Endovascular AAA System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Percept Deep Brain Stimulation Therapy System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX Endovascular AAA System

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROPACE RNS SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX VELA PROXIMAL ENDOGRAFT DELIVERY SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·INTEGRITY AFX DR/INTEGRITY SR

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·INTEGRITY/BRADYCARDIA REFERENCE/PATIENT MANUAL

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX ENDOVASCULAR AAA SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX ENDOVASCULAR AAA SYSTEM