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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 (Model L131); PROPONENT MRI (Model L231); ACCOLADE MRI (Model L331); ESSENTIO™ MRI (Models L110, L111); PRO
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP150012
Supplement NumberS191
Date Received09/15/2026
Decision Date10/03/2026
Product Codes NVN LWP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
to implement an additional acceptance activity for Accolade SL batteries and to change a specification for an existing Accolade EL battery specification
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