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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 111 Results
productcode LWS PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
 
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Device
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PMA
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Subcutaneous Implantable Cardiac Defibrillators, E... BOSTON SCIENTIFIC CORPORATION P110042 S166 12/29/2021
RELIANCE 4-FRONT™ BOSTON SCIENTIFIC P910073 S165 12/23/2021
SICD Gen 2, SICD MRI BOSTON SCIENTIFIC CORPORATION P110042 S168 12/21/2021
ORIGEN™ MINI ICD VR, ORIGEN™ MINI ICD DR, INOGEN™ ... BOSTON SCIENTIFIC P960040 S474 12/21/2021
Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD MEDTRONIC CARDIAC RHYTHM DISEA P980016 S801 12/21/2021
Drug-Eluting Permanent Defibrillator Electrodes BIOTRONIK, INC. P980023 S110 12/20/2021
EMBLEM subcutaneous implantable cardioverter defib... BOSTON SCIENTIFIC CORPORATION P110042 S164 12/17/2021
Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, ... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S799 12/17/2021
Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, ... MEDTRONIC CARDIAC RHYTHM DISEA P980016 S800 12/09/2021
ACE Header End Cap, Epicardial Patch Lead, Upsizin... MEDTRONIC CARDIAC RHYTHM DISEA P900061 S167 12/07/2021
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