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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, AXIOS, BA03, CYLOS, DROMOS, KAIROS, PHILOS, PHILOS II, AND PROTOS FAMILIES OF PULSE GENERATORS
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pacemaker pulse generator,pacemaker programmer
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS059
Date Received05/15/2008
Decision Date11/04/2008
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of models 500/540 to the lumax family of icd/crt-ds and ics 3000 programmer. These models would contain: ¿ a third programmable cardioversion / defibrillation shock pathway to offer more programming options ¿ automatic threshold measurement (atm) feature ¿ electronic module (hardware) updates to support the third programmable shock path ¿ modifications to the litronik batteries to increase capacity ¿ new standard value of the programmable pacing pulse width ¿ updated ram firmware to support new features.
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