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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 PACEMAKER & PHILOS II PACEMAKERS & ICS 3000 IMPLANT CONTROL SYSTEM & IMPLANT MODULE
Generic NamePulse generator, permanent, implantable
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS053
Date Received07/13/2007
Decision Date12/07/2007
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE APPLICATION SOFTWARE VERSION A-K00.10U OF THE PMS/TMS 1000, AND APPLICATION SOFTWARE VERSION 703.U/1 OF THE ICS 3000.
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