Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Aurora EV ICD

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX Anti-HBe, LIAISON® XL MUREX Control Anti-HBe

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·IsoMed Infusion System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Mara Water Vapor Probe

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·ECLIPSE TMR HOLMIUM LASER SYSTEM

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SINGLE CHAMBER PACEMAKERS

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FluoroPerm 92, FluoroPerm 60, FluoroPerm 30, FluoroPerm 151, HDS and HDS 100

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MyCareLink and MyCareLink Smart Patient Monitor

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CapSure Epicardial Pacing Lead

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL® Absorbable Hemostats

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CareLink Express Monitor, Monitor CardioSight Reader, My CareLink Patient Monitor.

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Evolut R Transcatheter Aortic Valve (TAV)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED II PUMP

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II BIOPROSTHESIS MODEL T505

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Dexcom G5 Platinum Contiuous Glucose Monitoring System

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilesto 7 VR-T DX, Ilesto 7 VR-T, Ilesto 5 VR-T DX, Ilesto 5 VR-T, Iforia 7 VR-T DX, Ilesto 7 VR-T (DF4), Ilesto 5 VR-T (