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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.
 
DeviceVITATRON DA + C-SERIESAND VITATRON DA + T-SERIES
Generic NamePulse generator, permanent, implantable
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP990001
Supplement NumberS080
Date Received12/07/2010
Decision Date03/22/2011
Product Code NVZ 
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 DESIGN CHANGES TO THE MULTILAYER CERAMIC CAPACITORS (XC308, XC251, XC259, AND XC263) FOR CONCERTO II MODEL D274TRK; CONSULTA MODEL D224TRK; AND MAXIMO II MODELD284TRK; MAXIMO II MODELS D284DRG, D2S4VRC; SECURA MODELS D224DRG, D224VRC; ANDVIRTUOSO MODELS D274DRG. D274VRG; ENRHYTHM MODEL P1501DR; VITATRON DA+ C- SERIES MODELS C20A1, C20A3, C60A1, C60A3; AND VITATRON DA+ T-SERIES MODELS T2OA1, T6OA1;
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