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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.
 
DeviceSECURA DR/VR MAXIMO II DR/VR AND VIRTUOSO II DR/VR
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP980016
Supplement NumberS164
Date Received10/22/2008
Decision Date03/31/2009
Product Code LWS 
Advisory Committee Cardiovascular
Clinical TrialsNCT00279279
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE MODEL 9995 V1.2 APPLICATION SOFTWARE WHICH INCLUDES THE LEAD INTEGRITY ALERT FEATURE AND ADDITIONAL SOFTWARE UPDATES.
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