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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.
 
DevicePROGRAMMER SOFTWARE (ICS 3000 802.U/2)
Generic NamePulse generator, permanent, implantable
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS067
Date Received11/17/2008
Decision Date03/31/2009
Product Code NVZ 
Advisory Committee Cardiovascular
Clinical TrialsNCT00508391
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR: 1) COMMERCIAL DISTRIBUTION OF THE LUMAX HF-T CRT-DS AND STRATOS LV (-T) CRT-PS WITH VENTRICLE TO VENTRICLE (V-V) DELAY FEATURES; AND 2) UPDATED MODEL ICS 3000 PROGRAMMER SOFTWARE (RELEASE OF 802.U/2) TO IMPLEMENT THE V-V DELAY FEATURES AND OTHER MINOR ENHANCEMENTS.
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