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.
 
DeviceVICI VENOUS STENT System
Generic NameStent, iliac vein
ApplicantBoston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752
PMA NumberP180013
Supplement NumberS007
Date Received04/06/2021
Decision Date06/29/2021
Product Code QAN 
Advisory Committee Cardiovascular
Clinical TrialsNCT02112877
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for labeling update which incorporates the final 3-year results from the VIRTUS Continued Follow-Up Study of patients enrolled in the premarket study
-
-