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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 CRT DEVICE & CARDIOMESSENGER II
Classification Namedefibrillator, implantable, dual-chamber
ApplicantBIOTRONIK, INC.
PMA NumberP050023
Supplement NumberS003
Date Received01/25/2007
Decision Date02/13/2007
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 modifications to the cardiomessenger and cardiomessenger ii used with the referenced devices. The devices, as modified, will be marketed under the trade names: cardiomessenger tline and cardiomessenger ii llt and are indicated for transmitting diagnostic patient data from the device to the physician.
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