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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.
 
DeviceEpsila EV Extravascular Lead
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic, Inc.
8200 Coral Sea Street NE
MV MVS11
Mounds View, MN 55112
PMA NumberP220012
Supplement NumberS022
Date Received04/05/2024
Decision Date04/16/2024
Product Codes LWS NVY 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
to transfer extrusion operations for multiple CRM components from the Santa Rosa facility to the Danvers facility
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