PMA P040037S088

Device: GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S088
Product code: NIP
Decision date: 2016-02-04
Classification: Stent, Superficial Femoral Artery
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: Use of an alternate resin in the manufacture of ePTFE fiber of the zipper component of the device, modification to raw material specification requirement and obtaining the alternate resin directly in the form of precursor tapes from the existing supplier.

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: S088
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2016-02-04
Decision code: OK30
Date received: 2016-01-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Use of an alternate resin in the manufacture of ePTFE fiber of the zipper component of the device, modification to raw material specification requirement and obtaining the alternate resin directly in the form of precursor tapes from the existing supplier.