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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 product family and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family
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 NumberS143
Date Received02/19/2021
Decision Date08/02/2021
Product Code NIP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval of a new ethylene oxide sterilization cycle to be performed at a new sterilization site (Sterigenics US, LLC located at 2400 Airport Road, Santa Teresa, NM)
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