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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.
 
DeviceNavitor™ TAVI System with Vision Technology
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP190023
Supplement NumberS029
Date Received12/05/2025
Decision Date06/03/2026
Product Code NPT 
Advisory Committee Cardiovascular
Clinical TrialsNCT02000115
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for modifications to the Instructions for Use to reflect the 5-year findings of the Post-Approval Study (PAS) Report submitted for the long term follow-up of the Portico TAVI System prospective cohort study
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