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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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Subcutaneous ICD Device (S-ICD): EMBLEM, EMBLEM MR... BOSTON SCIENTIFIC CORPORATION P110042 S104 03/12/2018
EMBLEM S-ICD; EMBLEM MRI S-ICD BOSTON SCIENTIFIC CORPORATION P110042 S103 02/08/2018
Subcutaneous Implantable Cardioverter Defibrillato... BOSTON SCIENTIFIC CORPORATION P110042 S099 01/16/2018
Subcutaneous Implantable Cardioverter Defibrillato... BOSTON SCIENTIFIC CORPORATION P110042 S100 01/12/2018
EMBLEM MRI S-ICD; EMBLEM S-ICD BOSTON SCIENTIFIC CORPORATION P110042 S101 01/10/2018
Emblem, Emblem MRI S-ICDs BOSTON SCIENTIFIC CORPORATION P110042 S098 12/19/2017
Emblem BOSTON SCIENTIFIC CORPORATION P110042 S092 12/13/2017
EMBLEM SICD GEN 2, SICD EMBLEM MRI , Subcutaneous ... BOSTON SCIENTIFIC CORPORATION P110042 S097 12/06/2017
Emblem S-ICD System Model A209 / Emblem MRI S-ICD ... BOSTON SCIENTIFIC CORPORATION P110042 S096 12/01/2017
EMBLEM Subcutaneous Implantable Defibrillator (S-I... BOSTON SCIENTIFIC CORPORATION P110042 S095 11/27/2017
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