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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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11 to 20 of 187 Results
Applicant BOSTON SCIENTIFIC CORPORATION productcode LWS Decision Date To 04/25/2024
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PMA
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EMBLEM™ Subcutaneous Implantable Cardioverter Defi... BOSTON SCIENTIFIC CORPORATION P110042 S182 05/12/2023
Subcutaneous Implantable Cardioverter Defibrillato... BOSTON SCIENTIFIC CORPORATION P110042 S183 05/11/2023
Level VIII Controlled Environment Area (CEA), Leve... BOSTON SCIENTIFIC CORPORATION P110042 S184 05/01/2023
EMBLEM S-ICD BOSTON SCIENTIFIC CORPORATION P110042 S178 04/21/2023
Telemetry Wand BOSTON SCIENTIFIC CORPORATION P110042 S179 03/14/2023
EMBLEM S-ICD, EMBLEM MRI S-ICD, BOSTON SCIENTIFIC CORPORATION P110042 S180 02/21/2023
Subcutaneous ICD Devices BOSTON SCIENTIFIC CORPORATION P110042 S173 12/20/2022
SICD Gen 2, SICD MRI BOSTON SCIENTIFIC CORPORATION P110042 S177 12/14/2022
Subcutaneous Implantable Cardioverter Defibrillato... BOSTON SCIENTIFIC CORPORATION P110042 S174 12/12/2022
EMBLEM™ Subcutaneous Implantable Cardioverter Defi... BOSTON SCIENTIFIC CORPORATION P110042 S176 12/07/2022
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