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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 NumberS017
Date Received07/30/1998
Decision Date08/21/1998
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 modifications to the DISCOVERY and MERIDIAN pacemakers consisting of changes to the firmware to enhance the performance of existing diagnostic features, and a hardware change to the mixed mode integrated circuit chip to increase the maximum selectable pacing amplitude.
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