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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 HOME MONITORING SYSTEM
Classification Nameimplantable pacemaker pulse-generator
Generic Namehome monitoring system
Regulation Number870.3610
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS031
Date Received02/06/2003
Decision Date02/25/2003
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for optimized circuitry, upgraded modem, upgraded battery, and aesthetic changes.
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