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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.
 
DeviceTendyne™ Transcatheter Mitral Valve System
Generic NameProsthesis, mitral valve, percutaneously delivered
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP240042
Supplement NumberS002
Date Received09/04/2025
Decision Date10/04/2025
Product Code NPU 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the protocol for the post-approval study, "Registry-Based Real-World Use Surveillance," submitted to comply with the conditions of approval outlined in the approval order for P240042.
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