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investigational device exemption

   Also found in: Dictionary/thesaurus, Acronyms, Encyclopedia, Wikipedia 0.01 sec.
investigational device exemption (IDE)
[inves′tigā′shənəl]
Etymology: L, investigare, to search for
an agreement through which the federal government permits the testing of new medical devices.


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Berlin, Germany, announced its Excor Pediatric ventricular assist device (VAD) has received unconditional approval from the FDA for the ongoing Investigational Device Exemption (IDE) in the US.
FDA wrote that the company does not have an approved application for premarket approval (PMA) or for an investigational device exemption (IDE.
reports that its subsidiary, Med Enclosure, LLC, has submitted an Investigational Device Exemption ("IDE") application to the U.
 
 
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