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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.
 
DeviceAdapta,Versa, Sensia IPG, Advisa DR IPG, DR MRI IPG, SR MRI IPG, Relia IPG, Sphera DR MRI IPG
Generic NamePulse generator, permanent, implantable
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP980035
Supplement NumberS581
Date Received03/08/2019
Decision Date06/06/2019
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 minor design (material) changes and related manufacturing process changes to the tantalum capacitors used in select product families of ICDs and IPGs.
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