PMA P040037S055

Device: GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S055
Product code: NIP
Decision date: 2013-10-04
Classification: Stent, Superficial Femoral Artery
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: USE OF AN ALTERNATE POLYTETRAFLUORO-ETHYLENE (PTFE) RESIN RAW MATERIAL AND AN ALTERNATE MANUFACTURING AID DURING THE OVERWRAP PROCESS.

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: S055
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2013-10-04
Decision code: OK30
Date received: 2013-09-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: USE OF AN ALTERNATE POLYTETRAFLUORO-ETHYLENE (PTFE) RESIN RAW MATERIAL AND AN ALTERNATE MANUFACTURING AID DURING THE OVERWRAP PROCESS.