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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.
 
DeviceLATITUDE NXT 2.0 PATIENT MANAGEMENT SYSTEM
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP910077
Supplement NumberS140
Date Received11/20/2013
Decision Date06/20/2014
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview Memo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE LATITUDE NXT 2.0 SOFTWARE FOR THE WAVE COMMUNICATOR MODEL 6460, CHANGES TO THE WAVE COMMUNICATOR 6280, APPROVAL OF THE WAVE COMMUNICATOR 6290, AND UPDATES TO THE COMMUNICATION SOFTWARE FOR WAVE COMMUNICATOR MODELS 6498 AND6476.
Approval OrderApproval Order
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