PMA P040037S060
- Device
- GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040037
- Supplement
- S060
- Product code
- NIP
- Decision date
- 2014-09-19
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- APPROVAL FOR THE GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. THESE DEVICES ARE INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN SUPERFICIAL FEMORAL ARTERY DE NOVO AND RESTENOTIC LESIONS UP TO 270 MM IN LENGTH WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0 ¿ 7.5 MM. THESE DEVICES ARE ALSO INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN SUPERFICIAL FEMORAL ARTERY IN-STENT RESTENOTIC LESIONS UP TO 270 MM IN LENGTH WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0 ¿ 6.5 MM.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040037S060B.pdf" target="_new">Summary of Safety and Effectiveness</a>
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
- S060
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2014-09-19
- Decision code
- APPR
- Date received
- 2013-12-02
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. THESE DEVICES ARE INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN SUPERFICIAL FEMORAL ARTERY DE NOVO AND RESTENOTIC LESIONS UP TO 270 MM IN LENGTH WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0 ¿ 7.5 MM. THESE DEVICES ARE ALSO INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN SUPERFICIAL FEMORAL ARTERY IN-STENT RESTENOTIC LESIONS UP TO 270 MM IN LENGTH WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0 ¿ 6.5 MM.