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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 NameLEXOS & LUMOS FAMILIES OF ICDS
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cv defibrillator/pacemaker programmer/icd monitoring system
ApplicantBIOTRONIK, INC.
PMA NumberP000009
Supplement NumberS031
Date Received11/04/2008
Decision Date11/21/2008
Product Code
MRM[ Registered Establishments with MRM ]
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.
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