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Can the sponsor change the manufacturing site of the Premarket Approval (PMA) approved medical device?
Yes, however, the sponsor must receive FDA approval of the new manufacturing site prior to distributing product that was manufactured at the new facility. For additional information about PMA Manufacturing Site Change Supplements, contact Field Operations Branch at 240-276-0194.
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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