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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCYLOS FAMILY OF PULSE GENERATORS
Generic Namepermanent pacemaker Electrode
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS041
Date Received09/26/2005
Decision Date12/21/2005
Product Codes DTB DXY 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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