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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/ENTOVIS/ESTELLA/EFFECTA/ECURO
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, OR 97035
PMA NumberP950037
Supplement NumberS098
Date Received08/19/2011
Decision Date09/30/2011
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
APPROVAL FOR THE RENAMIC PROGRAMMER AND SOFTWARE VERSION PSW 1101.U.
Approval Order Approval Order
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