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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 NameLUMAX FAMILY OF ICD AND CRT-D
Classification Namedefibrillator, implantable, dual-chamber
ApplicantBIOTRONIK, INC.
PMA NumberP050023
Supplement NumberS057
Date Received11/20/2012
Decision Date02/12/2013
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for three separate modifications to the batteries used in the pulse generators.
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