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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEVIA DR, EVIA DR-T,EVIA SR, EVIA SR-T,ENTOVIS DR, ENTOVIS DR-T,ENTOVIS SR,ENTOVIS SR-T,ESTELLA SR,ESTELLA SR-T,ECURO DR,
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, OR 97035
PMA NumberP950037
Supplement NumberS118
Date Received01/14/2013
Decision Date02/19/2013
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
RECLASSIFYING THE ENVIRONMENTAL CONDITIONS FROM CLASS D TO ISO 8 CLEANROOMS.
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