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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Applicant BOSTON SCIENTIFIC CORP. productcode LWP Decision Date To 04/18/2024
 
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PMA
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(Pacemaker Devices) ADVANTIO, INGENIO, VITALIO, FO... Boston Scientific Corp. N970003 S251 06/15/2020
- ESSENTIO™ SR, ESSENTIO™ DR, SSENTIO™ EL DR, PROP... Boston Scientific Corp. N970003 S287 07/21/2023
Accessory Wrench Socket Cap Brady/Tachy Boston Scientific Corp. N970003 S237 04/08/2019
Accolade Family of Devices Pacemakers, and Cardiac... Boston Scientific Corp. N970003 S280 12/12/2022
Accolade Non-MRI Pacemakers , Altrua, Essentio, Pr... Boston Scientific Corp. N970003 S210 08/30/2017
Accolade Non-MRI Pacemakers: ADVANTIO, INGENIO, VI... Boston Scientific Corp. N970003 S226 03/12/2018
Accolade Non-MRI Pacemakers: ALTRUA 2, ESSENTIO, P... Boston Scientific Corp. N970003 S219 12/11/2017
Accolade Non-MRI Pacemakers: ALTRUA 2, ESSENTIO, P... Boston Scientific Corp. N970003 S216 10/20/2017
Accolade Pacemakers Boston Scientific Corp. N970003 S235 02/19/2019
Accolade Pacemakers Boston Scientific Corp. N970003 S240 06/21/2019
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