PMA P040037S084

Device: GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S084
Product code: NIP
Decision date: 2015-08-04
Classification: Stent, Superficial Femoral Artery
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: IMPLEMENTATION OF A SUPPLIER PROCESS CHANGE TO THE TEMPERATURE SETTING OF THE CURING OVEN USED IN THE MANUFACTURING PROCESS OF A CATHETER COMPONENT.

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: S084
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2015-08-04
Decision code: OK30
Date received: 2015-07-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: IMPLEMENTATION OF A SUPPLIER PROCESS CHANGE TO THE TEMPERATURE SETTING OF THE CURING OVEN USED IN THE MANUFACTURING PROCESS OF A CATHETER COMPONENT.