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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.
 
DeviceSTELID II BFT/BJF/STELIX BR/STELIX II BRF
Classification Namepermanent defibrillator electrodes
Generic Namepermanent defibrillator electrodes
Applicant
LivaNova USA, Inc.
100 cyberonics blvd.
houston, TX 77058
PMA NumberP020030
Supplement NumberS008
Date Received02/28/2011
Decision Date03/31/2011
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
UPDATE TO THE CURRENT LEADS LABEL PRINTING SOFTWARE.
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