Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, and Evera XT VR ICD

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

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

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV-T,EVIA HF-T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·BELOS, LEXOS, LUMOS, and XELOS

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·Vertiflex Instrument Platform (VIP) Kit

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK Automated External Defibrillator (AED)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC RESTORESENSOR NEUROSTIMULATOR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MYCARELINK PATIENT MONITOR

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACANALYSIS CDX

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·THERA/THERA-I PRODIGY SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MyCareLink Patient Monitor Model 24950

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Platinum VR and DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD's

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MASTERS SERIES COATED AORTIC VALVED GRAFT

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SUBCUTANEOUS ICD DEVICES: EMBLEM.

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·APPLICATION SOFTWARE, PROVIT SOFTWARE, VITATRON C20 SR IPG, VITATRON C60 DR IPG, VITATRON T20 SR IPG, VITATRON T60 DR

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·IOPN PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACUITY SPIRAL, EASYTRAK 2, EASYTRAK 3

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEURO CYBERNETIC PROSTHESIS (NCP) SYSTEM

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APLIGRAF