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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 ICDS & CRT-DS
Classification Namedefibrillator, implantable, dual-chamber
ApplicantBIOTRONIK, INC.
PMA NumberP050023
Supplement NumberS008
Date Received12/10/2007
Decision Date03/11/2008
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the chemical formulation of the manganese binding agent used in the construction of batteries to ptfe dispersion dyneon tf 5032 r.
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