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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 SLR PULSE GENERATOR
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse generator; pacemaker programmer
Regulation Number870.3610
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS013
Date Received05/08/2000
Decision Date10/13/2000
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for removal of the warning label which recommended programming dynamic hysteresis on when the device is programmed to the vddr mode.
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