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premarket approval

   Also found in: Acronyms, Encyclopedia, Wikipedia 0.01 sec.
premarket approval (PMA)
[-mar′kit]
permission given by the federal government to equipment manufacturers to sell their devices to the medical profession.

premarket approval
Medical devices A scientific and regulatory review by the FDA to ensure the safety and effectiveness of a Class III device, before its approval for marketing. See Advisory panel, Medical device.


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Danvers, MA announced the FDA has approved its Premarket Approval Application (PMA) supplement for its AB Portable driver.
The agency warned that the firm must obtain premarket approval to market the devices.
5 warning letter, FDA stated that the significant changes of the company's QCT Bone Mineral Analysis Systems would now indicate that they are Class III devices, which had neither premarket approval or an investigational device exemption (IDE).
 
 
 
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