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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 AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Classification Namestent, superficial femoral artery
ApplicantW.L. GORE & ASSOCIATES,INC
PMA NumberP040037
Supplement NumberS060
Date Received12/02/2013
Decision Date09/19/2014
Product Code
NIP[ Registered Establishments with NIP ]
Docket Number 14M-1452
Notice Date 10/14/2014
Advisory Committee Cardiovascular
Clinical Trials NCT01108861
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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