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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 10/22/2021
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PMA
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subcutaneous icd devices emblem BOSTON SCIENTIFIC CORPORATION P110042 S086 08/07/2017
model 2889 emblem s-icd automated screening tool, ... BOSTON SCIENTIFIC CORPORATION P110042 S067 07/06/2017
subcutaneous implantable defibrillator (s-icd) emb... BOSTON SCIENTIFIC CORPORATION P110042 S085 06/06/2017
emblem s-icd pulse generator (pg) & mri s-icd pul... BOSTON SCIENTIFIC CORPORATION P110042 S084 05/23/2017
model a219 emblem mri s-icd pulse generator; model... BOSTON SCIENTIFIC CORPORATION P110042 S080 05/19/2017
all flex 4-socket hi-pot/pulse test system BOSTON SCIENTIFIC CORPORATION P110042 S082 04/23/2017
emblem subcutaneous icd's BOSTON SCIENTIFIC CORPORATION P110042 S068 04/17/2017
emblem™ s-icd model a209; emblem™ mri s-icd model ... BOSTON SCIENTIFIC CORPORATION P110042 S081 04/13/2017
emblem s-icd programmer - plexus smt mfg. line BOSTON SCIENTIFIC CORPORATION P110042 S079 03/21/2017
subcutaneous implantable defibrillator (s-icd) sys... BOSTON SCIENTIFIC CORPORATION P110042 S078 03/06/2017
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