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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.
 
DeviceESTELLA AND EFFECTA PULSE GENERATORS
Generic NamePulse generator, permanent, implantable
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS092
Date Received12/13/2010
Decision Date02/11/2011
Product Code NVZ 
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 THE ICS 3000 PROGRAMMER APPLICATION SOFTWARE VERSION PSW 1004.U, AND THE ESTELLA DR; ESTELLA DR-T; ESTELLA SR; ESTELLA SR-T; ECURO DR; ECURO DR-T; ECURO SR; ECURO SR-T; EFFECTA D; EFFECTA DR; EFFECTA S; AND EFFECTA SR. THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES LISTED ABOVE, AND IS INDICATED FOR THE APPROVED INDICATION FOR USE.
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