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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 04/25/2024
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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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