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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.
 
DeviceDISCOVERY/MERIDIAN PACEMAKER SYSTEMS
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP940031
Supplement NumberS021
Date Received10/04/1999
Decision Date10/20/1999
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 Software Application Model 2890 Revision 3.27 which removes automatic Minute Ventilation (MV) initialization, adds a "pop-up" warning ont he programmer screen prior to manual MV initialization, and corrects several minor anomalies applicable to the entire PDM pacemaker line.
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