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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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EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) - 00690103194340

EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (23MM)
Edwards Lifesciences LLC
9600TFX
In Commercial Distribution

  • 00690103194340 ()

  • 23 MM
9600TFX23A

  • Pulmonary transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) - 00690103194005

EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (20MM)
Edwards Lifesciences LLC
9600TFX
In Commercial Distribution

  • 00690103194005 ()

  • 23 MM
9600TFX20A

  • Pulmonary transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

EDWARDS COMMANDER DELIVERY SYSTEM - 00690103193961

EDWARDS COMMANDER DELIVERY SYSTEM
Edwards Lifesciences LLC
9600LDS29
In Commercial Distribution

  • 00690103193961 ()

  • 29 MM
9600LDS29A

  • Pulmonary transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

EDWARDS COMMANDER DELIVERY SYSTEM - 00690103193930

EDWARDS COMMANDER DELIVERY SYSTEM
Edwards Lifesciences LLC
9600LDS20
In Commercial Distribution

  • 00690103193930 ()

  • 20 MM
9600LDS20A

  • Pulmonary transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) - 00690103193176

EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (29MM)
Edwards Lifesciences LLC
9300TFX
In Commercial Distribution

  • 00690103193176 ()

  • 29 MILIMETER OUTER DIAMETER EXPANDED VALVE
9300TFX29A

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
  • Pulmonary transcatheter heart valve bioprosthesis

EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) - 00690103192087

EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (26MM)
Edwards Lifesciences LLC
9300TFX
In Commercial Distribution

  • 00690103192087 ()

  • 26 MILIMETER OUTER DIAMETER EXPANDED VALVE
9300TFX26A

  • Pulmonary transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) - 00690103192070

EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (23MM)
Edwards Lifesciences LLC
9300TFX
In Commercial Distribution

  • 00690103192070 ()

  • 23 MILIMETER OUTER DIAMETER EXPANDED VALVE
9300TFX23A

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
  • Pulmonary transcatheter heart valve bioprosthesis

Aveir™ - 05415067040725

Leadless Pacemaker
ST. JUDE MEDICAL, INC.
LSP202V
In Commercial Distribution

  • 05415067040725 ()
LSP202V

  • Intracardiac pacemaker

Aveir™ - 05415067040701

Leadless Pacemaker
ST. JUDE MEDICAL, INC.
LSP201A
In Commercial Distribution

  • 05415067040701 ()
LSP201A

  • Intracardiac pacemaker

Aveir™ - 05415067034472

Leadless Pacemaker
ST. JUDE MEDICAL, INC.
LSP112V
In Commercial Distribution

  • 05415067034472 ()
LSP112V

  • Intracardiac pacemaker
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