PMA P130006S103

Device: GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Applicant: W. L. Gore & Associates, Inc.
PMA number: P130006
Supplement: S103
Product code: PFV
Decision date: 2024-02-28
Classification: Cardiovascular
Generic name: System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Approval order statement: implementation of a new Automatic Transfer, Align, and Tape (ATAT) machine

Current openFDA PMA Record#

Device: GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Applicant: W. L. Gore & Associates, Inc.
PMA number: P130006
Supplement: S103
Product code: PFV
Generic name: System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Decision date: 2024-02-28
Decision code: OK30
Date received: 2024-02-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementation of a new Automatic Transfer, Align, and Tape (ATAT) machine