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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 DR/DR-T/VR/VR-T AND LUMOS DR-T/VR-T ICDS
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cv defibrillator/pacemaker programmer/icd monitoring system
ApplicantBIOTRONIK, INC.
PMA NumberP000009
Supplement NumberS039
Date Received05/28/2010
Decision Date07/30/2010
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at sterigenics germany gmbh, wiesbaden, germany as an alternate sterilization facility.
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