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.
 
DeviceGORE VIATORR TIPS ENDOPROSTHESIS
Generic NameSHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
ApplicantW. L. GORE & ASSOCIATES, INC.
32360 N NORTH VALLEY PARKWAY
PHOENIX, AZ 85085
PMA NumberP040027
Supplement NumberS002
Date Received09/19/2005
Decision Date12/08/2005
Product Code MIR 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO CHANGE CERTAIN MANUFACTURING PROCESSES FROM A MANUAL PROCESS TO A SEMI-AUTOMATED PROCESS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GORE VIATORR TIPS ENDOPROSTHESIS AND IS INDICATED FOR USE IN DE NOVO AND REVISION TREATMENT OF PORTAL HYPERTENSION AND ITS COMPLICATIONS SUCH AS VARICEAL BLEEDING, GASTROPATHY, ASCITES, AND/OR HEPATIC HYDROTHORAX.
-
-