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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.
 
DeviceKAINOX VCS,LINOX,LINOX SMART,VIGILA,VOLTA
Generic NamePermanent defibrillator electrodes
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS055
Date Received04/29/2013
Decision Date05/29/2013
Product Code NVY 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
A CHANGE IN STERILIZATION LOAD CONFIGURATION; 2) CHANGE IN STERILIZATION PRE-CONDITIONING; 3) STERILIZATION INJECTION PARAMETER CHANGES; AND 4) CHANGE TO THEPROCESS CHALLENGE DEVICE.
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