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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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Emblem S-ICD Electrode 45cm BOSTON SCIENTIFIC CORPORATION P110042 S124 04/08/2019
Subcutaneous Implantable Cardioverter Defibrillat... BOSTON SCIENTIFIC CORPORATION P110042 S122 03/27/2019
Emblem S-ICD, Electrode BOSTON SCIENTIFIC CORPORATION P110042 S120 02/28/2019
EMBLEM (Subcutaneous ICD Devices) BOSTON SCIENTIFIC CORPORATION P110042 S119 02/22/2019
Subcutaneous Implantable Cardioverter Defibrillato... BOSTON SCIENTIFIC CORPORATION P110042 S121 01/23/2019
EMBLEM S-ICD Pulse Generator; EMBLEM MRI S-ICD Pul... BOSTON SCIENTIFIC CORPORATION P110042 S117 12/06/2018
EMBLEM S-ICD PG Models A209 and A219 BOSTON SCIENTIFIC CORPORATION P110042 S118 11/29/2018
EMBLEM, EMBLEM MRI BOSTON SCIENTIFIC CORPORATION P110042 S116 11/16/2018
Subcutaneous Implantable Cardioverter Defibrillato... BOSTON SCIENTIFIC CORPORATION P110042 S114 10/24/2018
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYS... BOSTON SCIENTIFIC CORPORATION P110042 S115 10/10/2018
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