FDA.reportPublic FDA data

PMA P130006S099

Device
GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
Applicant
W. L. Gore & Associates, Inc.
PMA number
P130006
Supplement
S099
Product code
PFV
Decision date
2023-07-05
Classification
Cardiovascular
Generic name
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Approval order statement
Implementation of an alternate supplier of the outer foil packaging of the following devices: GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface, GORE VIABAHN VBX Balloon Expandable Endoprosthesis and GORE TAG Thoracic Branch Endoprosthesis.

Current openFDA PMA Record#

Device
GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
Applicant
W. L. Gore & Associates, Inc.
PMA number
P130006
Supplement
S099
Product code
PFV
Generic name
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Decision date
2023-07-05
Decision code
OK30
Date received
2023-06-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of an alternate supplier of the outer foil packaging of the following devices: GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface, GORE VIABAHN VBX Balloon Expandable Endoprosthesis and GORE TAG Thoracic Branch Endoprosthesis.