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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.
 
DevicePercepta Bipolar CRT-P, Quadripolar CRT-P, Serena Bipolar CRT-P, Quadripolar CRT-P, Solara Bipolar CRT-P, Quadripolar CR
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP010015
Supplement NumberS391
Date Received02/05/2019
Decision Date03/27/2019
Product Codes NKE LWP 
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 a replacement Multi-Layer Ceramic Capacitor used in select Medtronic pacemakers and cardiac resynchronization therapy pacemakers.
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