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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 SR, ENTOVIS DR, ENTOVIS SR, ESTELLA DR, ESTELLA SR, EFFECTA D, EFFECTA DR, EFFECTA S, EFFECTA SR, 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 NumberS114
Date Received12/03/2012
Decision Date12/19/2012
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 
ALTERNATE SUPPLIER FOR THE SNAP-CAN HOUSING.
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