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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 Transcatheter Aortic Valve Implantation System
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP190023
Supplement NumberS034
Date Received06/12/2026
Decision Date07/09/2026
Product Code NPT 
Advisory Committee Cardiovascular
Clinical TrialsNCT04011722
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 revised protocol for the post-approval study (PAS)
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