PMA P040037S126

Device: GORE VIABAHN Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S126
Product code: NIP
Decision date: 2019-02-13
Classification: Stent, Superficial Femoral Artery
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: Implementation of a new edge trim laser for use in the manufacture of the GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface.

Current openFDA PMA Record#

Device: GORE VIABAHN Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S126
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2019-02-13
Decision code: OK30
Date received: 2019-01-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of a new edge trim laser for use in the manufacture of the GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface.