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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.
 
DeviceHeartLogic™
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantBoston Scientific Corp.
4100 HAMLINE AVE NORTH
ST. PAUL, MN 55112
PMA NumberP010012
Supplement NumberS571
Date Received05/24/2023
Decision Date11/15/2023
Product Code NIK 
Advisory Committee Cardiovascular
Clinical TrialsNCT03237858
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for updated labeling to include information regarding the Multiple Cardiac Sensors for the Management of Heart Failure (MANAGE-HF) Post Approval Study 2 (PAS002) for the HeartLogic feature utilizing real-world data from the Boston Scientific Device Tracking Database (TRaC II), Center for Medicaid and Medicare Services Administrative Claims Database (CMS claims), and the Boston Scientific LATITUDE NXT Patient Management System (LATITUDE System).
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