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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 NumberS147
Date Received10/21/2020
Decision Date11/16/2020
Product Codes NVY LWS 
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  
Implement a new manufacturing process for the front desiccant/liner components and remove a supplier of low voltage capacitors.
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