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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantW.L. GORE & ASSOCIATES,INC
3450 WEST KILTIE LN.
P.O. BOX 500
FLAGSTAFF, AZ 86002-0500
PMA NumberP040037
Supplement NumberS060
Date Received12/02/2013
Decision Date09/19/2014
Product Code NIP 
Docket Number 14M-1452
Notice Date 10/14/2014
Advisory Committee Cardiovascular
Clinical TrialsNCT01108861
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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