PMA P040037S013

Device: GORE VIABAHN ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S013
Product code: NIP
Decision date: 2009-06-25
Classification: Stent, Superficial Femoral Artery
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: APPROVAL TO MODIFY THE DESIGN PLATFORM OF THE LARGE DIAMETER DEVICE (9-13MM DIAMETER) SO THAT IT IS IDENTICAL TO THE CURRENTLY APPROVED SMALLER DIAMETER DEVICES. THE DESIGN PLATFORM MODIFICATION INCLUDES CHANGES TO THE DELIVERY SYSTEM AND ASSOCIATED MANUFACTURING CHANGES.

Current openFDA PMA Record#

Device: GORE VIABAHN ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S013
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2009-06-25
Decision code: APPR
Date received: 2008-12-09
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO MODIFY THE DESIGN PLATFORM OF THE LARGE DIAMETER DEVICE (9-13MM DIAMETER) SO THAT IT IS IDENTICAL TO THE CURRENTLY APPROVED SMALLER DIAMETER DEVICES. THE DESIGN PLATFORM MODIFICATION INCLUDES CHANGES TO THE DELIVERY SYSTEM AND ASSOCIATED MANUFACTURING CHANGES.