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U.S. Department of Health and Human Services

Devices@FDA
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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.
 
DeviceVARIOUS MODELS OF PACEMAKERS ICS 3000/ EPR 1000 PLUS
Generic NamePulse generator, permanent, implantable
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS045
Date Received06/29/2006
Decision Date07/26/2006
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR PROGRAMMER SOFTWARE MODIFICATIONS (601.U AND A-K00.8.U) FOR USE IN BIOTRONIK PACEMAKERS AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS. THE MODIFICATIONS INCLUDED ADDING THE 1-OPT FEATURE, EXPANDING PROGRAMMER CAPABILITIES, IMPROVING PRINTING AND DATA IMPORT/EXPORT CAPABILITIES, ENHANCING COMMUNICATION AND MEMORY, UPDATING PROGRAMMABILITY AND RAM AND CORRECTING SOFTWARE ANOMALIES. THE SOFTWARE IS FOR USE WITH EPR 1000 PLUS PROGRAMMING SYSTEM, TMS 1000 PLUS PROGRAMMING SYSTEM AND ICS 3000 IMPLANT CONTROL SYSTEM.
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