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 has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceGORE VIATORR TIPS
Generic NameSHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
ApplicantW. L. GORE & ASSOCIATES, INC.
32360 N NORTH VALLEY PARKWAY
PHOENIX, AZ 85085
PMA NumberP040027
Date Received06/09/2004
Decision Date12/06/2004
Product Code MIR 
Docket Number 06M-0411
Notice Date 10/17/2006
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE GORE VIATORR TIPS ENDOPROSTHESIS. THE DEVICE 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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements: S029 S030  S033 S034 S035 S036 S037 S024 S025 S026 S046 
S042 S043 S044 S015 S016 S001 S009 S006 S007 S003 S019 S014 
S013 S020 S002 S004 S005 S053 S054 S032 S038 S045 S040 S041 
S047 S028 S039 S031 S010 S011 S017 S021 S022 S012 S018 S008 
S048 S051 S056 S052 S049 S050 S064 S065 S063 S057 S070 S071 
S072 S075 S076 S079 S078 S068 S088 S087 S093 S058 S059 S060 
S061 S073 S069 S077 S082 S074 S066 S067 S091 S080 S081 S084 
S085 S086 S092 S090 S089 S095 S096 S094 
-
-