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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 NumberS009
Date Received01/26/2009
Decision Date05/12/2009
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Clinical Trials NCT00336284
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of product labeling for devices that utilize home monitoring. Specifically, supplements requested approval for the replacement of existing precautions and the following marketing statements: 1) biotronic home monitoring information may be used as a replacement for device interrogation during in-office follow-up visits. 2) a strategy of care using biotronik home monitoring with office visits when needed - has been shown to extend the lime between routine, scheduled in-office follow-ups of biotronik implantable devices in many patients. Home monitoring data is helpful in determining the need for additional in-office follow-up. 3) biotronik home monitoring patients -who are followed remotely with office visits when needed - have been shown to have similar numbers of strokes, invasive procedures and deaths as patients followed with conventional in-office follow-ups. 4) biotronik home monitoring provides early detection of arrhythmias. 5) biotronik home monitoring provides early detection of silent, asymptomatic arrhythmias. 6) automatic early detection of arrhythmias and device system anomalies by biotronik home monitoring allows for earlier intervention than conventional in-office follow-ups. 7) biotronik home monitoring allows for improved access to patient device data compared to conventional in-office follow-ups since device interrogation is automatically scheduled at regular intervals.
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