FDA.reportPublic FDA data

PMA P130006S100

Device
GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
Applicant
W. L. Gore & Associates, Inc.
PMA number
P130006
Supplement
S100
Product code
PFV
Decision date
2023-07-18
Classification
Cardiovascular
Generic name
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Approval order statement
Removal of post-deployment visual and deployment force quality control inspection steps for the GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesiswith Heparin Bioactive Surface.

Current openFDA PMA Record#

Device
GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
Applicant
W. L. Gore & Associates, Inc.
PMA number
P130006
Supplement
S100
Product code
PFV
Generic name
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Decision date
2023-07-18
Decision code
OK30
Date received
2023-06-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Removal of post-deployment visual and deployment force quality control inspection steps for the GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesiswith Heparin Bioactive Surface.