Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

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 ·Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MY CARELINK PATIENT MONITOR MODEL 24950

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF/ATLAS+ HF FAMILY OF CRT-DS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·PASSIVE FIXATION SJ4 LEADS

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

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER/FRONTIER II FAMILY OF CRT-PS

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MICRONY FAMILY OF PACEMAKERS

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

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL, TENDRIL ST, TENDRIL STS, AND OPTISENSE LEADS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·PASSIVE PLUS, ISOFLEX S&P, AND ISOFLEX OPTIM LEADS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 25000 MY CARELINK SMART READER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MY CARE-LINK SMART MONITOR PATIENT READER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·Monovisc High Molecular Weight Hyaluronan

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·EUFLEXXA (1% SODIUM HYALURONATE)

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·HYALGAN