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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DELIV SYS NU1022 ENSEMBLE HDE
MEDTRONIC, INC.
NU1022
Not in Commercial Distribution

  • 00643169415768 ()

  • Outer Balloon Size 22 MM


  • Pulmonary transcatheter heart valve bioprosthesis
DELIV SYS NU1020 ENSEMBLE HDE
MEDTRONIC, INC.
NU1020
Not in Commercial Distribution

  • 00643169415744 ()

  • Outer Balloon Size 20 MM


  • Pulmonary transcatheter heart valve bioprosthesis
DELIV SYS NU1018 ENSEMBLE HDE
MEDTRONIC, INC.
NU1018
Not in Commercial Distribution

  • 00643169415720 ()

  • Outer Balloon Size 18 MM


  • Pulmonary transcatheter heart valve bioprosthesis
TOOL NU1020 ENSEMBLE HDE
MEDTRONIC, INC.
NU1020
Not in Commercial Distribution

  • 00613994665997 ()

  • Outer Balloon Size 20 MM


  • Pulmonary transcatheter heart valve bioprosthesis
VALVE PB1018 MELODY HDE
MEDTRONIC, INC.
PB1018
Not in Commercial Distribution

  • 00613994663962 ()

  • Valve Size 18 MM


  • Pulmonary transcatheter heart valve bioprosthesis
TOOL NU1022 ENSEMBLE HDE
MEDTRONIC, INC.
NU1022
Not in Commercial Distribution

  • 00613994666000 ()

  • Outer Balloon Size 22 MM


  • Pulmonary transcatheter heart valve bioprosthesis
TOOL NU1018 ENSEMBLE HDE
MEDTRONIC, INC.
NU1018
Not in Commercial Distribution

  • 00613994665980 ()

  • Outer Balloon Size 18 MM


  • Pulmonary transcatheter heart valve bioprosthesis
SAPIEN 3 PULMONIC DELIVERY SYSTEM - 29MM (US)
Edwards Lifesciences LLC
9630PL29A
In Commercial Distribution

  • 00690103210873 ()

  • Balloon Diameter: 29.0000 Millimeter
9630PL29A

  • Pulmonary transcatheter heart valve bioprosthesis
ALTERRA ADAPTIVE PRESTENT SYSTEM (US) 40MM X 48MM
Edwards Lifesciences LLC
29AP4045
In Commercial Distribution

  • 00690103210866 ()
29AP4045A

  • Pulmonary transcatheter heart valve bioprosthesis
DELIV SYS NU1022 ENSEMBLE US
MEDTRONIC, INC.
NU1022
Not in Commercial Distribution

  • 00643169588455 ()

  • Outer Balloon Size 22 MM


  • Pulmonary transcatheter heart valve bioprosthesis
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