PMA P040037S076

Device: GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN, ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S076
Product code: NIP
Decision date: 2014-11-21
Classification: Stent, Superficial Femoral Artery
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: MODIFICATIONS TO THE STRIPPING MACHINE USED DURING REMOVAL OF GRAFT COMPONENTS FROM THE PROCESS MANDREL.

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: S076
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2014-11-21
Decision code: OK30
Date received: 2014-10-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MODIFICATIONS TO THE STRIPPING MACHINE USED DURING REMOVAL OF GRAFT COMPONENTS FROM THE PROCESS MANDREL.