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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 ICD Devices
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBOSTON SCIENTIFIC CORPORATION
4100 HAMLINE AVENUE NORTH
ST. PAUL, MN 55112-5798
PMA NumberP110042
Supplement NumberS159
Date Received09/03/2021
Decision Date11/30/2021
Product Codes LWS NVY 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a software maintenance release (SMR) to the Model 3300 LATITUDE Programming System and the release of the Model 3894 LATITUDE Consult software application.
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