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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 Automated Screening Tool
Generic Nameimplantable cardioverter defibrillator (non-crt)
Applicant
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
st. paul, MN 55112-5798
PMA NumberP110042
Supplement NumberS129
Date Received10/15/2019
Decision Date12/16/2019
Product Codes NVY  LWS 
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Automatic Screening Tool on the Model 3300 LATITUDE Programming System and associated changes to the existing programming system support software Multiple Application Utility and Data Manager.
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