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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™ Titan Valve
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP190023
Supplement NumberS023
Date Received09/23/2024
Decision Date10/22/2024
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  
an alternative nitinol tubing supplier for the manufacturing of the 35 mm Navitor Titan Transcatheter Aortic Heart Valve (NVRO-35)
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