Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 NumberS025
Date Received01/31/2025
Decision Date05/07/2025
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a leaflet design change for the 23 mm and 25 mm Navitor Vision Valves, and an alternate inner and outer fabric cuff component supplier for all sizes (23 mm, 25 mm, 27 mm, 29 mm) of the Navitor Vision Valves
-
-