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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
Classification Namesystem, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment
ApplicantW.L. GORE & ASSOCIATES,INC
PMA NumberP130006
Supplement NumberS007
Date Received06/04/2014
Decision Date07/02/2014
Product Code
PFV[ Registered Establishments with PFV ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of an alternate bioburden extraction method and updating existing documents to allow for use of alternative/ additional organism strains and/or removal of specific microorganism strain designations and updated nomenclature in accordance with usp <61> and usp <62>.
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