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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 5 of 5 Results
productcode NRZ PMA Number p Decision Date From 1/1/2016 Decision Date To 1/1/2017
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Device
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Applicant
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PMA
Number
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Decision
Date
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InSightec ExAblate System INSIGHTEC, LTD P040003 S019 10/28/2016
EXABLATE 2000 SYSTEM INSIGHTEC, LTD P040003 S018 08/26/2016
EXABLATE InSightec P110039 S006 08/26/2016
EXABLATE 2000 SYSTEM INSIGHTEC, LTD P040003 S017 06/27/2016
EXABLATE InSightec P110039 S005 06/27/2016
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