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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 VR/DR/VIRTUOSO II DR/VR ICDS
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 NumberS241
Date Received05/20/2010
Decision Date07/15/2010
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN UPDATE TO COMPONENT PLANTING SPECIFICATION TITLED ¿MATERIAL, PLANTING, AND SURFACE FINISH REQUIREMENTS FOR TERMINALS FOR LASER RIBBON-BONDING (LRB), WIREBONDING (WB), AND PARALLEL GAP WELDING (PGW).¿ (REVISION O).
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