General

CurrencyCurrent through May 31, 2023
Citation 21 C.F.R. §814.80
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1 cases
  • White v. Stryker Corp., Civil Action No. 3:10–CV–544–H.
    • United States
    • U.S. District Court — Western District of Kentucky
    • 25 Marzo 2011
    ...approved a medical device through the PMA process, the applicant is required to comply with the standards in the PMA approval order. 21 C.F.R. § 814.80. The standard FDA “Conditions of Approval” accompanying a PMA approval order state that continued approval of the PMA “is contingent on the......

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