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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, Essentio, Proponent, and Accolade Non-MRI Pacemakers
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberN970003
Supplement NumberS241
Date Received06/20/2019
Decision Date09/18/2019
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for hardware modifications to the IS-1 lead bore cavity and spring coil in the IS-1 pulse generator header for all pacemakers and cardiac resynchronization therapy pacemakers within the Accolade family and a subset of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators within the NG3 and NG4 families.
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