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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 300/340 & 500/540 DR/DR-T/VR/VR-T ICD'S, LUMAX 540 VR-T DX ICD, KRONOS LV-T, LUMAX 300/340 & 500/540 HF/HF-T CRT-D
Classification Namedefibrillator, implantable, dual-chamber
PMA NumberP050023
Supplement NumberS077
Date Received06/23/2014
Decision Date11/17/2014
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the etrinsa, epyra and eluna pacemaker families with programmer software 1304. U for the renamic programmer and home monitoring service center with software version 3. 26. 0.