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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameGORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE
Classification Namestent, superficial femoral artery
ApplicantW.L. GORE & ASSOCIATES,INC
PMA NumberP040037
Supplement NumberS050
Date Received04/29/2013
Decision Date10/18/2013
Product Code
NIP[ Registered Establishments with NIP ]
Advisory Committee Cardiovascular
Clinical Trials NCT01263665
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a 25cm length for the 5-8mm diameter endoprostheses. The device, as modified, will be marketed under the trade name gore viabahn endoprosthesis and gore viabahn endoprosthesis with heparin bioactive surface and is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions up to 230 mm in length with reference vessel diameters ranging from 4. 0 ¿ 7. 5 mm. The gore viabahn endoprosthesis and gore viabahn endoprosthesis with heparin bioactive surface are also indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions up to 80 mm in length with reference vessel diameters ranging from 4. 0 ¿ 12 mm.
Post-Approval StudyShow Report Schedule and Study Progress
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