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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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EnSite™ Verismo™ - 05415067026293

Software Upgrade Kit, v.2.0.1
ST. JUDE MEDICAL, INC.
H702504
In Commercial Distribution

  • 05415067026293 ()
H702504

  • Cardiac mapping system application software

EnSite Precision™ - 05415067026279

Software Installation, v.1.0.1
ST. JUDE MEDICAL, INC.
H702503
In Commercial Distribution

  • 05415067026279 ()
H702503

  • 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

EnSite™ Fusion™ - 05415067026224

Software Upgrade Kit, v.7.1
ST. JUDE MEDICAL, INC.
H702506
In Commercial Distribution

  • 05415067026224 ()
H702506

  • Cardiac mapping system application software

EnSite™ Derexi™ - 05415067026217

Module, v.1.3.1
ST. JUDE MEDICAL, INC.
H702502
In Commercial Distribution

  • 05415067026217 ()
H702502

  • Cardiac mapping system application software

EnSite™ - 05415067026200

Software Upgrade Kit, 30 day license, v.2.0
ST. JUDE MEDICAL, INC.
Contact Force Module
In Commercial Distribution

  • 05415067026200 ()
H702500-T

  • Cardiac mapping system application software

EnSite™ - 05415067026194

Software Upgrade Kit, v.2.0
ST. JUDE MEDICAL, INC.
Contact Force Module
In Commercial Distribution

  • 05415067026194 ()
H702500

  • Cardiac mapping system application software

EnSite™ Courier™ - 05415067026187

Software Installation, 30 day trial, v.3.0
ST. JUDE MEDICAL, INC.
H702501-T
In Commercial Distribution

  • 05415067026187 ()
H702501-T

  • Cardiac mapping system application software

EnSite™ Courier™ - 05415067026170

Software Installation, v.3.0
ST. JUDE MEDICAL, INC.
H702501
In Commercial Distribution

  • 05415067026170 ()
H702501

  • Cardiac mapping system application software
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