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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 PATIENT MANAGEMENT SYSTEM, LATITUDE NXT RELEASE 3.0
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910077
Supplement NumberS143
Date Received05/27/2014
Decision Date07/16/2014
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE WAVE COMMUNICATOR MODEL 6280 SW VERSION V1.52.00;WAVE COMMUNICATOR MODEL 6290 SW VERSION V2.02.00;WAVE COMMUNICATOR MODEL 6498 SW VERSION V1.52.00;LATITUDE NXT SYSTEM SOFTWARE MODEL 6460 V.3.00.01; ANDCOMMUNICATOR ACCESSORY AND LITERATURE KIT MODEL 6250.
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