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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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S-ICD GEN 2, S-ICD EMBLEM MRI BOSTON SCIENTIFIC CORPORATION P110042 S175 10/28/2022
EMBLEM™ S-ICD, EMBLEM MRI S ICD BOSTON SCIENTIFIC CORPORATION P110042 S172 09/27/2022
SICD Gen 2 A209, SICD MRI A219 BOSTON SCIENTIFIC CORPORATION P110042 S171 07/13/2022
Emblem S-ICD, Emblem MRI S-ICD BOSTON SCIENTIFIC CORPORATION P110042 S170 06/21/2022
Subcutaneous Implantable Cardioverter Defibrillato... BOSTON SCIENTIFIC CORPORATION P110042 S169 05/18/2022
Subcutaneous ICD Devices BOSTON SCIENTIFIC CORPORATION P110042 S167 02/24/2022
Subcutaneous Implantable Cardiac Defibrillators, E... BOSTON SCIENTIFIC CORPORATION P110042 S166 12/29/2021
SICD Gen 2, SICD MRI BOSTON SCIENTIFIC CORPORATION P110042 S168 12/21/2021
EMBLEM subcutaneous implantable cardioverter defib... BOSTON SCIENTIFIC CORPORATION P110042 S164 12/17/2021
Subcutaneous ICD Devices BOSTON SCIENTIFIC CORPORATION P110042 S159 11/30/2021
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