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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.
 
DeviceModel A219 EMBLEM MRI S-ICD Pulse Generator; Model A209 EMBLEM S-ICD Pulse Generator; Model 2877 Programmer Software App
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific Corporation
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP110042
Supplement NumberS080
Date Received03/27/2017
Decision Date05/19/2017
Product Code LWS 
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 a firmware update to version 3.1.536 on the EMBLEM S-ICD Model A209 and EMBLEM MRI S-ICD Model A219 devices, and software version 4.03 for the Model 2877 Programmer Software.
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