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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 NamePROTOS DR/CLS, PROTOS VR/CLS, AXIOS DR, AXIOS D, AXIOS S, AXIOS SR, AND AXIOS SLR PULSE GENERATORS WITH PROGRAMMER SOFT
Classification Namepermanent pacemaker electrode
Generic Nameimplantable pacemaker pulse generator,pacemaker programmer
Regulation Number870.3680
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS032
Date Received02/28/2003
Decision Date03/31/2004
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding axvx adaptive rate pacing capability to the protos family of pulse generators, the addition of the data transfer utility software, and modifications to the axios family of pulse generators.
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