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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 300 DR-T,LUMAX 340 DR-T, LUMAX 300 VR-T, LUMAX 340 VR-T, LUMAX 500 DR-T, LUMAX 540 DR-T, LUMAX 500 VR-T, LUMAX 540
Classification Namedefibrillator, implantable, dual-chamber
ApplicantBIOTRONIK, INC.
PMA NumberP050023
Supplement NumberS059
Date Received12/21/2012
Decision Date01/31/2013
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 the updates to the home monitoring service center with 5 software versions, v3. 8. 1, v3. 9. 0, v3. 10. 0, v3. 11. 0, v3. 12. 0; and the cardiomessenger ii9-llt).
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