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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 and EMBLEM MRI S-ICD Pulse Generator
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific Corporation
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP110042
Supplement NumberS143
Date Received08/13/2020
Decision Date10/16/2020
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 to allow an additional mold release/de-nest agent to be applied to the polyethylene terephthalate glycol (PETG) sheets used to form sterile packaging.
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