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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 32 Results
productcode LWS PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
 
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PMA
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cobalt mri icd, cobalt xt mri icd, crome mri icd, ... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S855 05/17/2023
cobalt mri icd, cobalt xt mri icd, crome mri icd MEDTRONIC CARDIAC RHYTHM DISEA P980016 S854 05/16/2023
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
home monitoring system version 3.56.0 BIOTRONIK, INC. P980023 S119 05/11/2023
level viii controlled environment area (cea), leve... BOSTON SCIENTIFIC CORPORATION P110042 S184 05/01/2023
ellipse dr, ellipse vr Abbott Medical P910023 S453 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
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