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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™ - 05415067051134

X EP System
ST. JUDE MEDICAL, INC.
ENSITE-R-SYS-3.1
In Commercial Distribution

  • 05415067051134 ()
ENSITE-R-SYS-3.1

  • Cardiac mapping system

EnSite™ - 05415067051127

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-3.1
In Commercial Distribution

  • 05415067051127 ()
ENSITE-DWS-3.1

  • Cardiac mapping system

EnSite™ - 05415067051110

X EP System PFA Catheter Visualization Software License
ST. JUDE MEDICAL, INC.
ENSITE-FWV-02
In Commercial Distribution

  • 05415067051110 ()
ENSITE-FWV-02

  • Cardiac mapping system application software

EnSite™ - 05415067051103

X EP System Advisor HD Grid X Mapping Catheter, Sensor Enabled Software License
ST. JUDE MEDICAL, INC.
ENSITE-HDGX-01
In Commercial Distribution

  • 05415067051103 ()
ENSITE-HDGX-01

  • Cardiac mapping system application software

EnSite™ - 05415067051097

X EP System PFA Catheter Visualization Temporary Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FWV-02
In Commercial Distribution

  • 05415067051097 ()
ENSITE-D-FWV-02

  • Cardiac mapping system application software

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™ - 05415067048721

X Amplifier Air Filter
ST. JUDE MEDICAL, INC.
ENSITE-AAF-01
In Commercial Distribution

  • 05415067048721 ()
ENSITE-AAF-01

  • Cardiac mapping system

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
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