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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.
 
DeviceALTRUA™ 2 (Model S722); ESSENTIO™ (Model L121); PROPONENT™ (Model L221); ACCOLADE™ (Model L321); ALTRUA™ 2 (Models S701,
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberN970003
Supplement NumberS311
Date Received09/15/2026
Decision Date10/03/2026
Product Code LWP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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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