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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 NameCYLOS FAMILY OF PULSE GENERATORS
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse generator,pacemaker programmer
Regulation Number870.3610
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS041
Date Received09/26/2005
Decision Date12/21/2005
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 cylos dr/dr-t and cylos vr pulse generators and the a-k00. 6. U programmer software (for use with the epr 1000plus and tms 1000 plus programmers); the 504. U programmer software (for use with the ics 3000 programmer; and the home monitoring service center ii version 1. 8. 0.
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