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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.
 
DeviceMEDTRONIC PACEMAKER SYSTEMS
Generic NamePulse generator, permanent, implantable
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP980035
Supplement NumberS047
Date Received09/16/2005
Decision Date10/20/2005
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL TO ACTIVATE THE CAPABILITY TO REMOTELY UPDATE THE SOFTWARE IN CARELINK MONITOR MODELS 2490A/D/E/G/H/J, THE MODEL 2030A BATTERYCHECK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER WITH THE SOFTWARE VERSIONS SPECIFIED IN ATTACHMENT A FOR USE WITH THE PACEMAKERS AND IMPLANTABLE DEFIBRILLATORS AS SPECIFIED IN THE ATTACHMENT.
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