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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.
 
DevicePorticoTM, NavitorTM, and Navitor Titan Transcatheter Aortic Heart Valves
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP190023
Supplement NumberS016
Date Received10/02/2023
Decision Date11/07/2023
Product Code NPT 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
two new abattoirs as tissue suppliers and one new source country for collecting bovine pericardial tissue for the Portico, Navitor, and Navitor Titan valves
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