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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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EnVeo™ PRO - 00643169987180

LOAD SYS L-ENVPRO-16-US
MEDTRONIC, INC.
L-ENVPRO-16-US
In Commercial Distribution

  • 00643169987180 ()


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

EnVeo™ PRO - 00643169987173

LOAD SYS L-ENVPRO-14-US
MEDTRONIC, INC.
L-ENVPRO-14-US
In Commercial Distribution

  • 00643169987173 ()


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

Evolut™ PRO+ - 00763000207908

LOADING SYS L-EVPROP34US
MEDTRONIC COREVALVE LLC
L-EVPROP34US
In Commercial Distribution

  • 00763000207908 ()


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

Evolut™ PRO+ - 00763000207892

LOADING SYS L-EVPROP2329US
MEDTRONIC COREVALVE LLC
L-EVPROP2329US
In Commercial Distribution

  • 00763000207892 ()


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

Evolut™ PRO+ - 00763000207861

DELIV SYS D-EVPROP34US
MEDTRONIC COREVALVE LLC
D-EVPROP34US
In Commercial Distribution

  • 00763000207861 ()

  • Length: 107.0 Centimeter
  • Outer Diameter: 7.33 Millimeter


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

Evolut™ PRO+ - 00763000207854

DELIV SYS D-EVPROP2329US
MEDTRONIC COREVALVE LLC
D-EVPROP2329US
In Commercial Distribution

  • 00763000207854 ()

  • Length: 107.0 Centimeter
  • Outer Diameter: 6.0 Millimeter


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

WiSE CRT System - 00859244007029

Battery
EBR Systems, Inc.
3100
In Commercial Distribution

  • 00859244007029 ()


  • Implantable pacemaker battery

WiSE CRT System - 00859244007005

Transmitter
EBR Systems, Inc.
4100
In Commercial Distribution

  • 00859244007005 ()


  • Left-ventricular wireless pacing system sensor/transmitter

Ovation iX Iliac Stent Graft - 00850007370220

The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Limbs are comprised of a nitinol stent encapsulated in low-permeability PTFE. The iliac limbs are deployed into the leg sections of the aortic body. Additional iliac limbs may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-IL1414140-J
In Commercial Distribution

  • 00850007370220 ()

  • Stent Diameter: 14 Millimeter
  • Catheter Gauge: 60 French
  • Outer Diameter: 12 Femtometer
  • Lumen/Inner Diameter: 10 Femtometer
  • Stent Length: 140 Millimeter
TV-IL1414140-J

  • Abdominal aorta endovascular stent-graft

Ovation iX Iliac Stent Graft - 00850007370435

The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Limbs are comprised of a nitinol stent encapsulated in low-permeability PTFE. The iliac limbs are deployed into the leg sections of the aortic body. Additional iliac limbs may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-IL1414160-J
In Commercial Distribution

  • 00850007370435 ()

  • Stent Diameter: 14 Millimeter
  • Catheter Gauge: 60 French
  • Outer Diameter: 12 Femtometer
  • Lumen/Inner Diameter: 10 Femtometer
  • Stent Length: 160 Millimeter
TV-IL1414160-J

  • Abdominal aorta endovascular stent-graft
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