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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.
 
DeviceLATTITUDE CONSULT SYSTEM
Generic NamePacemaker/icd/crt non-implanted components
ApplicantBoston Scientific
4100 Hamline Ave. N.
Alternate Contact, MN 55112
PMA NumberP910077
Supplement NumberS138
Date Received09/25/2013
Decision Date03/20/2014
Product Code OSR 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR THE LATITUDE CONSULT SYSTEM WHICH INCLUDES THE COMMUNICATOR MODEL 6299 AND APPLICATION SOFTWARE SERVER MODEL 6294.
Approval OrderApproval Order
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