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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 & EMBLEM MRI S-ICD BOSTON SCIENTIFIC CORPORATION P110042 S113 09/05/2018
Emblem S-ICD, Emblem MRI S-ICD BOSTON SCIENTIFIC CORPORATION P110042 S112 09/04/2018
Emblem S-ICD Electrode BOSTON SCIENTIFIC CORPORATION P110042 S111 07/26/2018
EMBLEM S-ICD Pulse Generator (PG), EMBLEM MRI S-IC... BOSTON SCIENTIFIC CORPORATION P110042 S110 06/19/2018
S-ICD Pulse Generator, Emblem S-ICD, Emblem MRI S-... BOSTON SCIENTIFIC CORPORATION P110042 S108 06/01/2018
EMBLEM MRI S-CD/ EMBLEM S-CD Pulse Generator (PG) BOSTON SCIENTIFIC CORPORATION P110042 S107 05/15/2018
S-ICD Battery Anode Laser Edge Weld Process BOSTON SCIENTIFIC CORPORATION P110042 S109 05/08/2018
Subcutaneous Implantable Defibrillator (S-ICD) Sys... BOSTON SCIENTIFIC CORPORATION P110042 S106 04/25/2018
Emblem S-ICD Electrode Delivery System (model 4712... BOSTON SCIENTIFIC CORPORATION P110042 S102 04/19/2018
Subcutaneous Implantable Cardioverter Defibrillato... BOSTON SCIENTIFIC CORPORATION P110042 S105 03/28/2018
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