PMA P040037S002
- Device
- GORE VIABAHN ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040037
- Supplement
- S002
- Product code
- NIP
- Decision date
- 2007-02-08
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE ENDOPROSTHESIS AND DELIVERY CATHETER DESIGN TO REDUCE THE OVERALL DELIVERY PROFILE OF THE DEVICE BY ONE FRENCH SIZE.
Current openFDA PMA Record#
- Device
- GORE VIABAHN ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040037
- Supplement
- S002
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2007-02-08
- Decision code
- APPR
- Date received
- 2006-08-11
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE ENDOPROSTHESIS AND DELIVERY CATHETER DESIGN TO REDUCE THE OVERALL DELIVERY PROFILE OF THE DEVICE BY ONE FRENCH SIZE.