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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.
 
DeviceEMBLEM S-ICD pulse generator (PG) Models A209/A219
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific Corporation
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP110042
Supplement NumberS161
Date Received09/20/2021
Decision Date11/16/2021
Product Codes LWS NVY 
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 modifications to the hydrogen getter, transformer spacer component, and desiccant liner component of the EMBLEM S-ICD pulse generator Models A209/A219.
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