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.
 
DeviceNEXUS® Aortic Arch Stent Graft System
Generic NameEndovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions
ApplicantEndospan , Ltd.
105 Alta Meadows Rd.
Alta, WY 83414
PMA NumberP250033
Supplement NumberS001
Date Received04/23/2026
Decision Date05/20/2026
Product Code SDZ 
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  
implementation of a new clean room and associated controlled areas for manufacturing of the Nexus Aortic Arch Stent Graft System
-
-