• 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.
 
DeviceGORE VIABAHN EDOPROSTHESIS
Classification Namestent, superficial femoral artery
Generic Namestent, superficial femoral artery
Applicant
W.L. GORE & ASSOCIATES,INC
3450 west kiltie ln.
p.o. box 500
flagstaff, AZ 86002-0500
PMA NumberP040037
Supplement NumberS063
Date Received04/28/2014
Decision Date05/28/2014
Product Code
NIP[ Registered Establishments with NIP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
NEW SUPPLIER FOR BIOLOGICAL INDICATORS.
-
-