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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 NumberS002
Date Received10/18/2021
Decision Date01/13/2023
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 design changes including modification of the valve inner skirt material, addition of an outer skirt, and minor changes to the valve stent frame and loading system
Post-Approval StudyShow Report Schedule and Study Progress
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