VIABAHN ENDOPROSTHESIS
FDA premarket approval P040037 · decided 2005-06-14
Approval details
- PMA number
- P040037
- Trade name
- VIABAHN ENDOPROSTHESIS
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2004-08-27
- Decision date
- 2005-06-14
- Days to decision
- 291 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Flagstaff, AZ
- Statement
- APPROVAL FOR THE GORE VIABAHN ENDOPROSTHESIS. THE DEVICE IS INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN SUPERFICIAL FEMORAL ARTERY LESIONS WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.8 TO 7.5 MM.
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| GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (K181940) | W. L. Gore & Associates, Inc. | 2018-08-17 |
| GORE ENFORM Biomaterial (K173333) | W. L. Gore & Associates, Inc. | 2018-04-05 |