PMA P040037S125

Device: GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin BIoactive Surface
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S125
Product code: NIP
Decision date: 2019-01-02
Classification: Stent, Superficial Femoral Artery
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: Implementation of an alternate machine for use in nitinol wire manufacturing for the following devices: GORE EXCLUDER AAA Endoprosthesis, GORE VIATORR TIPS Endoprosthesis, GORE TAG Thoracic Endoprosthesis, GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface, GORE TIGRIS Vascular Stent and GORE CARDIOFORM Septal Occluder.

Current openFDA PMA Record#

Device: GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin BIoactive Surface
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S125
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2019-01-02
Decision code: OK30
Date received: 2018-12-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of an alternate machine for use in nitinol wire manufacturing for the following devices: GORE EXCLUDER AAA Endoprosthesis, GORE VIATORR TIPS Endoprosthesis, GORE TAG Thoracic Endoprosthesis, GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface, GORE TIGRIS Vascular Stent and GORE CARDIOFORM Septal Occluder.