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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.
 
DeviceRELIATY/MODEL 3145 PACING SYSTEM ANALYZER
Generic NamePulse generator, permanent, implantable
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS079
Date Received03/23/2010
Decision Date09/02/2010
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR A STAND-ALONE VERSION OF THE PACING SYSTEM ANALYZER FUNCTION FOUND IN THE ICS 3000 IMPLANT CONTROL SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RELIATY BY BIOTRONIK, INC. AND MODEL 3145 BY BOSTON SCIENTIFIC AND IS INDICATED FOR USE IN PACING LEAD SYSTEM ANALYSIS DURING THE IMPLANTATION OF PACEMAKERS AND DEFIBRILLATORS.
Approval OrderApproval Order
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