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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 Ave. N
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
Predetermined Change Control Plan AuthorizedNo
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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