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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.
 
DeviceMODEL 3120 ZOOM LATITUDE PROGRAMMER/ RECORDER/MONITOR, MODEL 3122 ANTENNA ACCESSORY, AND CONSULT PROGRAMMER SOFTWARE...
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910077
Supplement NumberS050
Date Received03/04/2005
Decision Date08/15/2005
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 ADDITION OF A SECOND INTERNAL ANTENNA TO THE MODEL 3120 ZOOM LATITUDE PROGRAMMER/RECORDER/MONITOR, A LABELING UPDATE FOR THE MODEL 3122 ANTENNA ACCESSORY, CONSULT PROGRAMMER SOFTWARE APPLICATION MODEL 2845 VERSION 4.12, AND MINOR MANUFACTURING PROCESS CHANGES.
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