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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/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T
Classification Namedefibrillator, implantable, dual-chamber
PMA NumberP050023
Supplement NumberS028
Date Received11/25/2009
Decision Date01/22/2010
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a software upgrade to version 902. U/1. This software is used in the ics 3000 system to program and interrogate all of biotronik¿s us market released bradycardia and tachycardia pacemakers.