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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Applicant BOSTON SCIENTIFIC productcode LWS
 
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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
NG3 Implantable Cardioverter Defibrillators (ICDs)... BOSTON SCIENTIFIC P960040 S491 05/11/2023
Level VIII Controlled Environment Area (CEA), Leve... BOSTON SCIENTIFIC CORPORATION P110042 S184 05/01/2023
Level VIII Controlled Environment Area (CEA), Leve... BOSTON SCIENTIFIC P960040 S492 05/01/2023
EMBLEM S-ICD BOSTON SCIENTIFIC CORPORATION P110042 S178 04/21/2023
LATITUDE™ NXT Release 7.3 BOSTON SCIENTIFIC P910077 S191 04/21/2023
TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN... BOSTON SCIENTIFIC P960040 S490 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

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