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.
 
DeviceZilver® PTX® Drug-Eluting Peripheral Stent
Generic NameStent, superficial femoral artery, drug-eluting
ApplicantCook Ireland, Ltd.
O'Halloran Road
National Technology Park
Limerick 
PMA NumberP100022
Supplement NumberS038
Date Received08/11/2021
Decision Date11/02/2021
Product Code NIU 
Advisory Committee Cardiovascular
Clinical TrialsNCT01901289
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for the addition of the US ZILVER PTX POST-APPROVAL STUDY 2 (PAS 2) results to the Instructions for Use
-
-