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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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Driveline Extension Cable - 00888707000024

No Description
Heartware Inc.
100US
Not in Commercial Distribution

  • 00888707000024 ()
100US

  • Implantable ventricular circulatory assist system

HVAD® Pump Implant Kit (Enhanced) - 00888707000017

No Description
Heartware Inc.
1103
Not in Commercial Distribution

  • 00888707000017 ()
1103

  • Implantable ventricular circulatory assist system

Thoratec® HeartMate 3™ - 00813024013297

LVAS Implant Kit
Thoratec Corporation
106524US
In Commercial Distribution

  • 00813024013297 ()
106524US

  • Implantable ventricular circulatory assist system

THORATEC® HeartMate 3™ LVAS Mini Kit - 00813024013198

No Description
Thoratec Corporation
10001696
In Commercial Distribution

  • 00813024013198 ()
10001696

  • Implantable ventricular circulatory assist system

Thoratec® HeartMate 3™ - 00813024013082

Mini Apical Cuff Kit
Thoratec Corporation
10005877
In Commercial Distribution

  • 00813024013082 ()
10005877

  • Implantable ventricular circulatory assist system

THORATEC® HEARTMATE II®, LVAS IMPLANT KIT, US, EP - 00813024010616

No Description
Thoratec Corporation
103695
In Commercial Distribution

  • 00813024010616 ()
103695

  • Implantable ventricular circulatory assist system

OPTIMIZER - 00810003380142

OPTIMIZER Lite Implantable Pulse Generator for the Treatment of Heart Failure System consists of: (1) OPTIMIZER Lite Implantable Pulse Generator (IPG) (1) Allen #2 torque wrench (1) Port Plug
Impulse Dynamics (usa) Inc.
Lite
In Commercial Distribution

  • 00810003380142 ()
10-B502-3-XX

  • Cardiac contractility modulation system pulse generator

OPTIMIZER - 00810003380098

OPTIMIZER Smart Mini Implantable Pulse Generator for the Treatment of Heart Failure System consists of: (1) OPTIMIZER Smart Mini Implantable Pulse Generator (IPG) (1) Allen #2 torque wrench (1) Port Plug
Impulse Dynamics (usa) Inc.
Smart Mini
In Commercial Distribution

  • 00810003380098 ()
10-B501-3-XX

  • Cardiac contractility modulation system pulse generator

OPTIMIZER™ - 00810003380050

OPTIMIZER Smart Implantable Pulse Generator for the Treatment of Heart Failure System consists of: (1) OPTIMIZER Smart Implantable Pulse Generator (IPG) (1) Allen #2 torque wrench (1) Port Plug
Impulse Dynamics (usa) Inc.
CCM X10
In Commercial Distribution

  • 00810003380050 ()
10-B411-3-XX

  • Cardiac contractility modulation system pulse generator

OPTIMIZER® - 00810003380005

OPTIMIZER Smart Implantable Pulse Generator for the Treatment of Heart Failure System consists of: (1) OPTIMIZER Smart Implantable Pulse Generator (IPG) (1) Allen #2 torque wrench (1) Port Plug
Impulse Dynamics (usa) Inc.
CCM X10
In Commercial Distribution

  • 00810003380005 ()
10-B411-3-US

  • Cardiac contractility modulation system pulse generator
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