PMA P040037S046
- Device
- GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040037
- Supplement
- S046
- Product code
- NIP
- Decision date
- 2013-04-18
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- ADD AN ALTERNATE SUPPLIER FOR THE TRANSITION COMPONENT OF THE ¿V3.18¿ CATHETER DELIVERY SYSTEM.
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
- S046
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2013-04-18
- Decision code
- OK30
- Date received
- 2013-03-21
- Supplement type
- 30-Day Notice
- Approval order statement
- ADD AN ALTERNATE SUPPLIER FOR THE TRANSITION COMPONENT OF THE ¿V3.18¿ CATHETER DELIVERY SYSTEM.