Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED DRUG PUMPS

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

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA AND SYNCRA CRT-P'S

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED II IMPLANTABLE INFUSION SYSTEM

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·INSYNC CRT-P & INSYNC III CRT-P

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Bipolar CRT-P W1TR01, Percepta Quadripolar CRT-P W4TR01, Serena Bipolar CRT-P W1TR02, Serena Quadripolar CRT-P

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·CERVISTA HPV 16/18

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE CV DEFIBRILLATOR/PACEMAKER PROGRAMMER/ICD MONITORING SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·2490G/H/J CARELINK MONITOR, 2020A CARDIOSIGHT READER

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Single/Dual Chamber ICD Systems, Bipolar CRT-D Systems and Acticor and Rivacor 1.5 T and 3.0 T ICD and CRT-D Systems

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix MRI Lead

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval

FDA Class 3 ·Barostim NEO Generator, Barostim NEO2 Generator, Barostim Carotid Sinus Lead, Programmer System, Carotid Sinus Lead Repa

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead and Attain OTW LV Lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Advisa DR, Advisa DR MRI, Advisa SR MRI, Astra S DR MRI, Astra S SR MRI, Asrtra XT DR MRI, Astra XT SR MRI, Azure S DR

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Home Monitoring System Version 3.52.0

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta,Versa,Sensia IPG, Adapta,Versa,Sensia IPG,Advisa DR IPG, Advisa DR MRI IPG,Advisa SR MRI IPG,Relia IPG

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™