PMA P040037S056

Device: GORE VIABAHN ENDOPROSTHESIS,GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S056
Product code: NIP
Decision date: 2013-10-16
Classification: Stent, Superficial Femoral Artery
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: CLARIFICATION TO AN INSPECTION ACCEPTANCE CRITERION FOR THE ASSEMBLED PROSTHESIS AND DELIVERY SYSTEM.

Current openFDA PMA Record#

Device: GORE VIABAHN ENDOPROSTHESIS,GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S056
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2013-10-16
Decision code: OK30
Date received: 2013-09-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CLARIFICATION TO AN INSPECTION ACCEPTANCE CRITERION FOR THE ASSEMBLED PROSTHESIS AND DELIVERY SYSTEM.