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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 NameECURO, EFFECTA, ESTELLA,EVIA, ENTOVIS IMPLANTABLE PACEMAKER
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pacemaker pulse generator,pacemaker programmer
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS126
Date Received07/16/2013
Decision Date08/14/2013
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implement a new ethylene oxide sterilization cycle at a contract sterilization site.
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