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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 (Subcutaneous ICD Devices)
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 NumberS119
Date Received12/03/2018
Decision Date02/22/2019
Product Code
LWS[ Registered Establishments with 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 changes to the Server and Communicator software updates necessary for LATITUDE NXT Release.
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