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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 CONSULT SYSTEM
Generic NamePacemaker/icd/crt non-implanted components
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP910077
Supplement NumberS147
Date Received09/05/2014
Decision Date11/06/2014
Product Code OSR 
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 THE LATITUDE CONSULT SYSTEM RELEASE 1.01 WHICH INCLUDES THE COMMUNICATOR MODEL 6299 AND APPLICATION SOFTWARE SERVER MODEL 6294.
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