Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Model 5071 Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Medtronic PCD Tachyarrhythmia Control System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Versatrax Model 7000 Universal A-V Pulse Generator

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain Starfix Model 4195 Lead

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Activitrax Models 8400, 8402, 8403

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Aurora EV-ICD System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Synergyst II Pulse Generator Models 7070 & 7071

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Medtronic.Kappa 400 Series Pacemakers

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

FDA Pre-Market Approval

FDA Class 3 ·Capsure SP, Capsure, Capsure 2 Leads, Excellence S, Impulse, Impulse II Excellence SS, Leads

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

FDA Pre-Market Approval

FDA Class 3 ·Medtronic (R) CapSure (R) EPI Pacing Lead

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HBV

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·ADEZA FETAL FIBRONECTIN EIK

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM RF CRT-D9750

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

FDA Pre-Market Approval

FDA Class 3 ·CONNECTOR SLEEVE ACCESSORY KIT

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

FDA Pre-Market Approval

FDA Class 3 ·UNIFY,UNIFY ASSURA,UNIFY QUADRA,QUADRA ASSURA CRT-DS