Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·INSPIRE II UPPER AIRWAY STIMULATOR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE GENERATOR AND PROGRAMMER SOFTWARE MODEL 3307, V2.2A

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ZEPHYR PULSE GENERATORS MODELS XL DR 5826,DR5820 & SR 5620

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SUSTAIN XL FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC.KAPPA 400 SERIES PACEMAKERS

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL P1501DR ENRHYTHM IMPLANTABLE PULSE GENERATOR, MEDTRONIC MODEL 9987 APPLICATION SOFTWARE AND MEDTRONIC MO

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·myChoice CDx

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·RESOLUTION ctDx FIRST

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Guardant360 CDx