PMA P040037S171

Device: GORE® VIABAHN® Endoprosthesis; GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S171
Product code: NIP
Decision date: 2025-10-17
Classification: Cardiovascular
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: implementation of an additional supplier of a raw material of the CBAS Heparin Surface

Current openFDA PMA Record#

Device: GORE® VIABAHN® Endoprosthesis; GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S171
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2025-10-17
Decision code: OK30
Date received: 2025-09-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementation of an additional supplier of a raw material of the CBAS Heparin Surface