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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Applicant BOSTONSCIENTIFIC productcode LWP
 
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PMA
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INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI... BOSTONSCIENTIFIC P150012 S155 04/30/2024
Essentio MRI SR, Essentio MRI DR, Essentio MRI EL ... BOSTONSCIENTIFIC P150012 S154 12/29/2023
ESSENTIO™ MRI SR, ESSENTIO™ MRI DR, ESSENTIO™ MRI ... BOSTONSCIENTIFIC P150012 S152 10/18/2023
INGEVITY™ and INGEVITY+TM active leads BOSTONSCIENTIFIC P150012 S150 10/13/2023
PG ACCOLADE MRI SR SL US, PG ACCOLADE MRI DR SL US... BOSTONSCIENTIFIC P150012 S151 10/06/2023
LD Ingevity Plus AF IS1 BOSTONSCIENTIFIC P150012 S149 09/08/2023
ACUITY Stylet, Straight 0.013, 45cm, ACUITY Stylet... BOSTONSCIENTIFIC P150012 S148 07/21/2023
INGEVITY™ MRI, INGEVITY™+ BOSTONSCIENTIFIC P150012 S147 07/06/2023
INGEVITY™ MRI Endocardial Steroid-eluting MR Condi... BOSTONSCIENTIFIC P150012 S146 06/29/2023
INGEVITY+ and INGEVITY MRI Pace/Sense leads BOSTONSCIENTIFIC P150012 S145 05/17/2023
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