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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 NamePHILOS DR-T PULSE GENERATOR AND A-K00.1.U/5 PROGRAMMER SOFTWARE
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse generator,pacemaker programmer
Regulation Number870.3610
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS037
Date Received02/13/2004
Decision Date03/31/2004
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of two cardio report triggers for the philos dr-t pulse generator and for revisions to the a-k00. 1. U/5 programmer software which are necessary in order to utilize the modified philos dr-t.
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