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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 MODELS: 6482 AND 6488
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910077
Supplement NumberS091
Date Received07/23/2008
Decision Date09/05/2008
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 CHANGES TO THE LATITUDE REGULATED APPLICATION SOFTWARE ON LATITUDE SYSTEM SERVER (MODEL 6488, VERSION 5.0).
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