Transcatheter Septal Occluder (Atrial)

FDA Pre-Market Approval

FDA Class 3 ·Occlutech ASD Occluder, Occlutech Pistol Pusher (OPP), Occlutech ASD Occluder Procedure Pack

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Base, Patient Connector, Host App, PSA App, Common App, and CareLink SmartSync Platform App

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·BD FOCALPOINT SLIDE PROFILER

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·Ambicor Inflatable Penile Prosthesis (IPP), AMS 700 IPP

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·INFINITY NEUROSTIMULATION SYSTEM

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·INFINITY NEUROSTIMULATION SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·HFX App

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Micra AV App, CareLink SmartSync Micra Evolution App, CareLink SmartSync Micra VR App

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Clinician Programmer Application Version 2.0.2, and Liberta RC DBS IPG Firmware Version 1.1.1

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Patient Controller Application Version 2.0.2

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync™ Micra VR App, CareLink SmartSync™ Micra AV App

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HearCare MED-EL, MAESTRO System Software 10.0

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

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P

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, ENOUKSE E2 IOG, KAPPA D IPG,KAPPA DR IP

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA MRI ICD, S DR ICD, S VR ICD, XT DR ICD, ST VR ICF, INTRINSIC 30 ICD, MARQUIS VR ICD, MAXIMO II ICD, PROTECT ICD, S

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

FDA Pre-Market Approval

FDA Class 3 ·BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D; MAXIMO II CRT-D, PROTECTA CRT-D, PROTECT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RENO MRI SURESCAN IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 31301 CARELINK EXPRESS APP.

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·NeuroSphere Digital Health Apps

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone, AMS Ambicor IPP