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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode POH PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
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Device
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Applicant
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PMA
Number
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Decision
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Exablate 4000 (“Neuro”) Type 1.0 & 1.1 InSightec P150038 S010 11/09/2020
ExAblate 4000 System (Exablate Neuro or the syste... InSightec P150038 S012 04/14/2020
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