FDA.reportPublic FDA data

PMA P160021S041

Device
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Applicant
W. L. Gore & Associates, Inc.
PMA number
P160021
Supplement
S041
Product code
PRL
Decision date
2023-07-05
Classification
Cardiovascular
Generic name
Iliac covered stent, arterial
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® VBX Balloon Expandable Endoprosthesis
Applicant
W. L. Gore & Associates, Inc.
PMA number
P160021
Supplement
S041
Product code
PRL
Generic name
Iliac covered stent, arterial
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.