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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.
 
DeviceCYLOS FAMILY OF PULSE GENERATORS
Classification Namepermanent pacemaker electrode
Generic Namepermanent pacemaker electrode
Regulation Number870.3680
Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, OR 97035
PMA NumberP950037
Supplement NumberS041
Date Received09/26/2005
Decision Date12/21/2005
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
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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