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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Applicant BOSTON SCIENTIFIC CORPORATION productcode LWS Decision Date To 10/22/2021
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Device
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PMA
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sicd gen 2 and sicd mri BOSTON SCIENTIFIC CORPORATION P110042 S135 03/17/2020
s-icd gen and s-icd emblem mri BOSTON SCIENTIFIC CORPORATION P110042 S134 03/05/2020
emblem subcutaneous implantable cardioverter defib... BOSTON SCIENTIFIC CORPORATION P110042 S131 12/19/2019
emblem s-icd automated screening tool BOSTON SCIENTIFIC CORPORATION P110042 S129 12/16/2019
subcutaneous implantable cardioverter defibrillato... BOSTON SCIENTIFIC CORPORATION P110042 S130 10/29/2019
emblem s-icd electrode BOSTON SCIENTIFIC CORPORATION P110042 S128 10/10/2019
subcutaneous implantable cardioverter defibrillato... BOSTON SCIENTIFIC CORPORATION P110042 S127 09/13/2019
emblem subcutaneous implantable cardioverter defib... BOSTON SCIENTIFIC CORPORATION P110042 S126 07/11/2019
subcutaneous icd devices: emblem BOSTON SCIENTIFIC CORPORATION P110042 S125 06/10/2019
emblem programmer BOSTON SCIENTIFIC CORPORATION P110042 S123 05/21/2019
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