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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 7 of 7 Results
productcode POH PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
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PMA
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Exablate 4000 System Type-1 (i.e. Type 1.0/1.1) InSightec P150038 S022 12/08/2022
Exablate Model 4000 Type 1.0 and 1.1 System (“Exab... InSightec P150038 S024 11/11/2022
Exablate Model 4000 Type 1.0 and 1.1 System (“Exab... InSightec P150038 S023 11/02/2022
Exablate Model 4000 Type 1.0 and 1.1 Systems InSightec P150038 S018 07/29/2022
Exablate 4000 (Exablate Neuro) InSightec P150038 S021 06/07/2022
Exablate Model 4000 System InSightec P150038 S019 04/06/2022
Exablate Model 4000 System InSightec P150038 S020 03/31/2022
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