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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 500/540 ICDS THORACIC IMPEDANCE
Classification Namedefibrillator, implantable, dual-chamber
ApplicantBIOTRONIK, INC.
PMA NumberP050023
Supplement NumberS047
Date Received08/22/2011
Decision Date11/17/2011
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for the addition of the thoracic impedance (ti) measurement feature to the currently approved lumax 500/540 implantable cardioverter defibrillators and cardiac resynchronization defibrillator devices.
Approval Order Approval Order
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