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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 NameACTROS AND KAIROS FAMILY OF PULSE GENERATORS WITH LITRONIK BATTERY
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse generator; pacemaker programmer
Regulation Number870.3610
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS017
Date Received09/27/2000
Decision Date05/24/2001
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of the litronik battery model lis 3150 in the actros+ and kairos pulse generator families.
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