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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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VNS Therapy® Model 250 v11.0 Programming Software - 05425025750375

Programming Software
LIVANOVA USA, INC.
250 v11.0
In Commercial Distribution

  • 05425025750375 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v11.0 Programming Software - 05425025750368

Programming Software
LIVANOVA USA, INC.
250 v11.0
In Commercial Distribution

  • 05425025750368 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v10.0 Programming Software - 05425025750214

Programming Software
LIVANOVA USA, INC.
250 v10.0
In Commercial Distribution

  • 05425025750214 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v8.1 Programming Software (X5) - 05425025750191

Programming Software
LIVANOVA USA, INC.
250 v8.1 (X5)
In Commercial Distribution

  • 05425025750191 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v8.1 Programming Software (X50) - 05425025750184

Programming Software
LIVANOVA USA, INC.
250 v8.1 (X50)
In Commercial Distribution

  • 05425025750184 ()


  • Vagus nerve electrical stimulation system programmer

ViewMate™ - 05415067030733

Software Upgrade
ST. JUDE MEDICAL, INC.
H900004
In Commercial Distribution

  • 05415067030733 ()
H900004

  • General-purpose ultrasound imaging system

EnSite Precision™ - 05415067030085

Software Installation
ST. JUDE MEDICAL, INC.
H702469-SW
In Commercial Distribution

  • 05415067030085 ()
H702469-SW

  • Cardiac mapping system application software

TactiCath™ Ablation Catheter, Sensor Enabled™ - 05415067028181

Software Installation
ST. JUDE MEDICAL, INC.
H702517-T
In Commercial Distribution

  • 05415067028181 ()
H702517-T

  • Cardiac mapping system application software

TactiCath™ Ablation Catheter, Sensor Enabled™ - 05415067028174

Software Installation
ST. JUDE MEDICAL, INC.
H702517
In Commercial Distribution

  • 05415067028174 ()
H702517

  • Cardiac mapping system application software

FlexAbility™ Ablation Catheter, Sensor Enabled™ - 05415067026248

Software Installation
ST. JUDE MEDICAL, INC.
H702509
In Commercial Distribution

  • 05415067026248 ()
H702509

  • Cardiac mapping system application software

Advisor™ FL Mapping Catheter, Sensor Enabled™ - 05415067026231

Software Installation
ST. JUDE MEDICAL, INC.
H702507
In Commercial Distribution

  • 05415067026231 ()
H702507

  • Electrical-only medical device connection adaptor, reusable

MediGuide™ - 05415067014672

Software Installation
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067014672 ()
MG1000

  • Cardiac mapping system

NA - 05415067040404

MerlinAtHome Software
ST. JUDE MEDICAL, INC.
EX2000
In Commercial Distribution

  • 05415067040404 ()
EX2000

  • Transtelephonic implantable pacemaker analysis system

EnSite™ - 05415067038098

Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-WS-01
In Commercial Distribution

  • 05415067038098 ()
ENSITE-D-WS-01

  • Cardiac mapping system application software

EnSite™ - 05415067037763

Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-1.1
In Commercial Distribution

  • 05415067037763 ()
ENSITE-SW-1.1

  • Cardiac mapping system application software

WorkMate™ Unity™ - 05415067035608

Software Installation
ST. JUDE MEDICAL, INC.
H800009
In Commercial Distribution

  • 05415067035608 ()
H800009

  • Cardiac catheterization monitoring system

WorkMate™ Unity™ - 05415067035578

Software Installation
ST. JUDE MEDICAL, INC.
H800010
In Commercial Distribution

  • 05415067035578 ()
H800010

  • Cardiac catheterization monitoring system

WorkMate™ Unity™ - 05415067035561

Software Installation
ST. JUDE MEDICAL, INC.
H800011
In Commercial Distribution

  • 05415067035561 ()
H800011

  • Cardiac catheterization monitoring system

EnSite Precision™ - 05415067035004

Software Installation
ST. JUDE MEDICAL, INC.
H702701
In Commercial Distribution

  • 05415067035004 ()
H702701

  • Cardiac mapping system application software

EnSite™ - 05415067033185

Software License
ST. JUDE MEDICAL, INC.
H702601
In Commercial Distribution

  • 05415067033185 ()
H702601

  • Cardiac mapping system application software
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