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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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CoreValve™ Evolut™ PRO - 00763000017835

VLV EVOLUTPRO-29-US BLUE COMM US
MEDTRONIC COREVALVE LLC
EVOLUTPRO-29-US
In Commercial Distribution

  • 00763000017835 ()

  • Valve Size 29 MM


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

CoreValve™ Evolut™ PRO - 00763000017811

VLV EVOLUTPRO-23-US BLUE COMM US
MEDTRONIC COREVALVE LLC
EVOLUTPRO-23-US
In Commercial Distribution

  • 00763000017811 ()

  • Valve Size 23 MM


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

CoreValve™ Evolut™ R - 00763000017675

VLV EVOLUTR-29-US GREY COMM US
MEDTRONIC COREVALVE LLC
EVOLUTR-29-US
In Commercial Distribution

  • 00763000017675 ()

  • Valve Size 29 MM


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

CoreValve™ Evolut™ R - 00763000017651

VLV EVOLUTR-23-US GREY COMM US
MEDTRONIC COREVALVE LLC
EVOLUTR-23-US
In Commercial Distribution

  • 00763000017651 ()

  • Valve Size 23 MM


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

CoreValve™ Evolut™ PRO - 00763000017828

VLV EVOLUTPRO-26-US BLUE COMM US
MEDTRONIC COREVALVE LLC
EVOLUTPRO-26-US
In Commercial Distribution

  • 00763000017828 ()

  • Valve Size 26 MM


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

CoreValve™ Evolut™ R - 00763000017682

VLV EVOLUTR-34-US BLUE COMM US
MEDTRONIC COREVALVE LLC
EVOLUTR-34-US
In Commercial Distribution

  • 00763000017682 ()

  • Valve Size 34 MM


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

CoreValve™ Evolut™ R - 00763000017668

VLV EVOLUTR-26-US GREY COMM US
MEDTRONIC COREVALVE LLC
EVOLUTR-26-US
In Commercial Distribution

  • 00763000017668 ()

  • Valve Size 26 MM


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

AMDS Hybrid Prosthesis ("AMDS") - 00877234001215

55mm Straight Stent (32mm collar)
Artivion, Inc.
K039422
In Commercial Distribution

  • 00877234001215 ()

  • Catheter Length: 565 Millimeter
  • Aortic Stent Proximal Diameter: 36-45mm
  • Aortic Stent Distal Diameter: 36-45mm
  • Aortic Stent Minimum Length:187mm
  • Aortic Stent Maximum Length:215mm
  • Stent Collar Diameter: 32mm
AMDS55

  • Bare-metal aortic stent

Navitor Titan™ - 05415067045768

Transcatheter Heart Valve
ST. JUDE MEDICAL, INC.
NVRO-35
In Commercial Distribution

  • 05415067045768 ()

  • Outer Diameter: 35.0000 Millimeter
NVRO-35

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

EDWARDS COMMANDER DELIVERY SYSTEM - 00690103193954

EDWARDS COMMANDER DELIVERY SYSTEM
Edwards Lifesciences LLC
9600LDS26
In Commercial Distribution

  • 00690103193954 ()

  • 26 MM
9600LDS26A

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