PMA P160021S047

Device: Reduced Profile GORE VIABAHN VBX Balloon Expandable Endoprosthesis (RP VBX Device)
Applicant: W. L. Gore & Associates, Inc.
PMA number: P160021
Supplement: S047
Product code: PRL
Decision date: 2025-05-20
Classification: Cardiovascular
Generic name: Iliac covered stent, arterial
Approval order statement: use of the Reduced Profile GORE VIABAHN VBX Balloon Expandable Endoprosthesis as a branch component option for the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE)

Current openFDA PMA Record#

Device: Reduced Profile GORE VIABAHN VBX Balloon Expandable Endoprosthesis (RP VBX Device)
Applicant: W. L. Gore & Associates, Inc.
PMA number: P160021
Supplement: S047
Product code: PRL
Generic name: Iliac covered stent, arterial
Decision date: 2025-05-20
Decision code: APPR
Date received: 2024-11-22
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: use of the Reduced Profile GORE VIABAHN VBX Balloon Expandable Endoprosthesis as a branch component option for the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE)