PMA P040037S007
- Device
- GORE VIABAHN ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040037
- Supplement
- S007
- Product code
- NIP
- Decision date
- 2008-08-14
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- APPROVAL OF AN EXTENSION OF THE INDICATIONS FOR USE TO INCLUDE ILIAC ARTERIAL LESIONS. THE DEVICE IS INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN ILIAC ARTERY LESIONS WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0-12.0 MM.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040037S007B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- GORE VIABAHN ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040037
- Supplement
- S007
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2008-08-14
- Decision code
- APPR
- Date received
- 2007-11-20
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL OF AN EXTENSION OF THE INDICATIONS FOR USE TO INCLUDE ILIAC ARTERIAL LESIONS. THE DEVICE IS INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN ILIAC ARTERY LESIONS WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0-12.0 MM.