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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 3501 EMBLEM S-ICD subcutaneous Electrode
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
Applicant
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
st. paul, MN 55112-5798
PMA NumberP110042
Supplement NumberS077
Date Received02/06/2017
Decision Date09/29/2017
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the EMBLEM S-ICD Electrode Model 3501 and labeling changes to the components of the EMBLEM S-ICD System.
Post-Approval StudyShow Report Schedule and Study Progress
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