PMA P040037S004

Device: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE S4URFACE
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S004
Product code: NIP
Decision date: 2007-07-31
Classification: Stent, Superficial Femoral Artery
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: APPROVAL OR THE ADDITION OF A HEPARIN COATING ON THE GORE VIABAHN ENDOPROSTHESIS, REFERRED TO AS THE HEPARIN BIOACTIVE SURFACE.

Current openFDA PMA Record#

Device: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE S4URFACE
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S004
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2007-07-31
Decision code: APPR
Date received: 2007-03-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL OR THE ADDITION OF A HEPARIN COATING ON THE GORE VIABAHN ENDOPROSTHESIS, REFERRED TO AS THE HEPARIN BIOACTIVE SURFACE.