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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.
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
PMA NumberP070008
Supplement NumberS007
Date Received11/04/2008
Decision Date11/21/2008
Product Code
NKE[ Registered Establishments with NKE ]
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 updates to the home monitoring service center used with the philos ii and cylos families of pulse generators lexos and lumos families of implantable cardioverter defibrillators. Stratos lv-t pulse generator. Cardiac airbag-t and belos vr-t implantable cardioverter defibrillators, and the kronos lv-t and lumax families of implantable cardioverter defibrillators.