PMA P040037S009

Device: GORE VIABAHN ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S009
Product code: NIP
Decision date: 2008-05-29
Classification: Stent, Superficial Femoral Artery
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: APPROVAL FOR: 1) A CHANGE IN THE TYPE OF COOLING GAS; 2) A CHANGE IN THE APPLICATION OF THE COOLANT; AND 3) THE ADDITION OF A TEMPERATURE CONTROLLER.

Current openFDA PMA Record#

Device: GORE VIABAHN ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S009
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2008-05-29
Decision code: APPR
Date received: 2008-01-22
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR: 1) A CHANGE IN THE TYPE OF COOLING GAS; 2) A CHANGE IN THE APPLICATION OF THE COOLANT; AND 3) THE ADDITION OF A TEMPERATURE CONTROLLER.