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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 NameVIRTUOSO MODELS D154AWG/D154VWC
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber icds
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS090
Date Received12/14/2006
Decision Date02/15/2007
Product Code
LWS[ Registered Establishments with LWS ]
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 firmware updates to 1) address a ?soft? rate limit power on reset, 2) load a temperature sensitivity update at the time of manufacturing, and 3) load optivol enhancements (for use outside of the united states only) at the time of manufacturing.
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