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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™ - 05415067050298

X EP System PFA Catheter Visualization Software License
ST. JUDE MEDICAL, INC.
ENSITE-FWV-01
In Commercial Distribution

  • 05415067050298 ()
ENSITE-FWV-01

  • Cardiac mapping system application software

EnSite™ - 05415067050281

X EP System PFA Catheter Visualization Temporary Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FWV-01
In Commercial Distribution

  • 05415067050281 ()
ENSITE-D-FWV-01

  • Cardiac mapping system application software

EnSite™ - 05415067050021

X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-3.0.2
In Commercial Distribution

  • 05415067050021 ()
ENSITE-TFM-3.0.2

  • Cardiac mapping system application software

EnSite™ - 05415067050014

X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-3.0.2
In Commercial Distribution

  • 05415067050014 ()
ENSITE-SW-3.0.2

  • Cardiac mapping system application software

EnSite™ - 05415067049988

X EP System OTA Certificate Software License
ST. JUDE MEDICAL, INC.
ENSITE-OTAC-02
In Commercial Distribution

  • 05415067049988 ()
ENSITE-OTAC-02

  • Cardiac mapping system application software

EnSite™ - 05415067049711

X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-3.1
In Commercial Distribution

  • 05415067049711 ()
ENSITE-TFM-3.1

  • Cardiac mapping system application software

EnSite™ - 05415067049704

X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-3.1
In Commercial Distribution

  • 05415067049704 ()
ENSITE-SW-3.1

  • Cardiac mapping system application software

EnSite™ - 05415067048400

X EP System Averaged Impedance Drop Software License
ST. JUDE MEDICAL, INC.
ENSITE-IMP-01
In Commercial Distribution

  • 05415067048400 ()
ENSITE-IMP-01

  • Cardiac mapping system application software

EnSite™ - 05415067048394

X EP System EnSite VoXel Flex Mode Software License
ST. JUDE MEDICAL, INC.
ENSITE-FLEX-01
In Commercial Distribution

  • 05415067048394 ()
ENSITE-FLEX-01

  • Cardiac mapping system application software

EnSite™ - 05415067048387

X EP System LiveSync Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-LS-01
In Commercial Distribution

  • 05415067048387 ()
ENSITE-D-LS-01

  • Cardiac mapping system application software
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