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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 91 Results
productcode LWS PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
 
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PMA
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Subcutaneous ICD Devices BOSTON SCIENTIFIC CORPORATION P110042 S173 12/20/2022
LATITUDE NXT Release 7.1.5 BOSTON SCIENTIFIC P910077 S188 12/20/2022
ICD Devices BOSTON SCIENTIFIC P960040 S483 12/20/2022
ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD ... BOSTON SCIENTIFIC P960040 S489 12/20/2022
Drug-Eluting Permanent Defibrillator Electrodes BIOTRONIK, INC. P980023 S117 12/16/2022
SICD Gen 2, SICD MRI BOSTON SCIENTIFIC CORPORATION P110042 S177 12/14/2022
LATITUDE Wave Communicator Model 6290 BOSTON SCIENTIFIC P910077 S190 12/14/2022
INOGEN™ MINI ICD VR, INOGEN™ MINI ICD DR, DYNAGEN™... BOSTON SCIENTIFIC P960040 S488 12/14/2022
Subcutaneous Implantable Cardioverter Defibrillato... BOSTON SCIENTIFIC CORPORATION P110042 S174 12/12/2022
Implantable Cardioverter Defibrillator (ICD) BOSTON SCIENTIFIC P960040 S484 12/12/2022
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