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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 NameCARDIOMESSENGER-S AND CARDIOMESSENGER-S TLINE
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pacemaker pulse generator,pacemaker programmer
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS081
Date Received05/12/2010
Decision Date06/18/2010
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the cardiomessenger-s and cardiomessenger-s tline.
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