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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 NameBIOTRONIK PACING AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pacemaker pulse generator,pacemaker programmer
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS044
Date Received04/10/2006
Decision Date02/15/2007
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the blister package and outer sales box.
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