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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.
 
DeviceSUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific Corporation
4100 Hamline Ave., N.
St. Paul, MN 55112-5798
PMA NumberP110042
Supplement NumberS058
Date Received02/12/2016
Decision Date08/08/2016
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the Model A219 EMBLEM MRI S-ICD as well as modifications to the Model A209 EMBLEM S-ICD, Model 3401 EMBLEM S-ICD Subcutaneous Electrode, Model 4711 EMBLEM S-ICD Subcutaneous Electrode Insertion Tool, Model 2877 Programmer Software Application and Model 3200 EMBLEM S-ICD Programmer.
Post-Approval StudyShow Report Schedule and Study Progress
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