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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.
 
DeviceConsulta CRT-P; Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P; Serena Bipolar CRT-P, Serena Quadripolar CRT-P; Sola
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP010015
Supplement NumberS395
Date Received03/04/2019
Decision Date03/21/2019
Product Code LWP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Changes to the biocontamination sample monitoring for devices that are processed outside the Controlled Environment Area (CEA).
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