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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceESSENTIO™ MRI (Models L110, L111, L131) PROPONENT™ MRI (Models L210, L211, L231) ACCOLADE™ MRI (Models L310, L311, L331)
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP150012
Supplement NumberS173
Date Received11/19/2025
Decision Date12/19/2025
Product Codes LWP NVN 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for the Software Maintenance Release 6 (SMR6) package of software updates for the ACCOLADE family of pacemakers and CRT-Ps
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