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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, Navitor Transcatheter Aortic Heart Valve, FlexNav Delivery Syste
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantAbbott Medical
177 County Road B. East
St. Paul, MN 55117
PMA NumberP190023
Supplement NumberS013
Date Received03/20/2023
Decision Date09/15/2023
Product Code NPT 
Advisory Committee Cardiovascular
Clinical TrialsNCT04011722
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a design modification to the Navitor Transcatheter Heart Valve for the addition of three radiopaque markers (RO markers) to the valve annulus section (Vision technology), minor changes to etching on the Navitor Loading System (LS LG+), and approval of the 35mm Navitor Titan size extension which will also incorporate the three RO markers.
Post-Approval StudyShow Report Schedule and Study Progress
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