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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 COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910077
Supplement NumberS077
Date Received09/05/2007
Decision Date11/06/2007
Product Code LWS 
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
Approval Order Statement  
APPROVAL FOR THE LATITUDE COMMUNICATOR SOFTWARE (MODEL 6482), VERSION 2.0 AND RELATED SYSTEM SOFTWARE (MODEL 6488) THAT CONTAINS REGULATED APPLICATION SERVER (RAS) SOFTWARE VERSION 2.3.0 AS WELL AS ASSOCIATED LABELING AND OPERATOR MANUAL UPDATES. THE SOFTWARE MODIFICATIONS ARE INTENDED TO SUPPORT NEW DEVICE MODELS, MAKE MINOR SOFTWARE CORRECTIONS, AND IMPROVE EASE OF USE WITH THE LATITUDE SYSTEM.
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