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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.
 
DeviceAdvanced Valve Metal (AVM) capacitor
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic, Inc.
8200 Coral Sea St. NE
Mv Mv S11
Mounds View, MN 55112
PMA NumberP220012
Supplement NumberS029
Date Received08/15/2024
Decision Date08/28/2024
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
addition of a new laser weld station to the advanced valve metal capacitor manufacturing process for ICD, and CRT-D devices
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