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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.
 
DeviceMERIDIAN AND DISCOVERY PACEMAKER SYSTEMS
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP940031
Supplement NumberS016
Date Received08/24/1998
Decision Date10/02/1998
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to the Model 2890 Software Application from Version 1.20 to Version 2.12 which consist primarily of usability changes (screen changes, usability features), corrections of anomalies, and the addition of a high rate single chamber temporary pacing mode (up to 380 ppm) to the DISCOVERY(TM)/MERIDIAN(TM) pacemakers which provides consistency with the VIGOR pacemakers.
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