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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.
 
DeviceVARIOUS FAMILIES OF ACTROS, AXIOS, 8A03, CYLOS, DROMOS, KAIROS, PHILOS, PROTOS, EVIA, ENTOVIS, ECURO, EFFECTA, & ESTELLA
Generic NamePulse generator, permanent, implantable
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS110
Date Received07/02/2012
Decision Date08/08/2012
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 UPDATED SOFTWARE VERSION PSW 1202.U.
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