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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameLIVIAN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) MODELS H220, H225, H227, AND H229
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namepulse generator
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS176
Date Received03/12/2008
Decision Date04/17/2008
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an updated header configuration for the confient and livian device families to include changed setscrews, seal plugs, and left ventricular ring lead wire routing (livian only) as well as the addition of a new model torque wrench.
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