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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 NameSTRATOS LV-T
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
ApplicantBIOTRONIK, INC.
PMA NumberP070008
Supplement NumberS003
Date Received06/04/2008
Decision Date06/24/2008
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a diode change in the stratos lv and lv-t crt-ps. The device, as modified, will be marketed under the trade name stratos lv crt-p and stratos lv-t crt-p and is indicated for treatment of bradycardia in heart failure patients.
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