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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
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber icds
Applicant MEDTRONIC INC.
PMA NumberP980016
Supplement NumberS118
Date Received12/10/2007
Decision Date01/03/2008
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor design changes that add alternate components, diodes (xd433, xd445) and capacitor (avx kyocera x5r), to the approved device components for use on the hybrid as well as minor associated modifications to the substrate. The design modifications are intended to increase supply line robustness, reduce component costs, and improve incoming component quality.
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