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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameKAIROS
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse generator, pacemaker programmer
Regulation Number870.3610
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS005
Date Received10/26/1998
Decision Date11/19/1998
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the kairos family of pulse generators with b-g00. 0. U programmer software for use with the model 1000/1000c programmers. As a discrete subset of the approved actros family of pulse generators, the kairos family is approved for the same indications.
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