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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVIRTUOSO,MARQUIS,MAXIMO,INTRINSIC & ENTRUST ICDS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MS MVS11
MOUNDS VIEW, MN 55112
PMA NumberP980016
Supplement NumberS101
Date Received04/24/2007
Decision Date06/25/2007
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE L325-03 AND L325-04 INTEGRATED CIRCUIT (IC) TO MINIMIZE THE POTENTIAL FOR A GATE-OXIDE BREAKDOWN WITHIN THE L325-01, L325-02, AND L281-04 ICS.
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