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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.
 
DeviceLINOX SMART
Generic NamePermanent defibrillator electrodes
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS047
Date Received08/29/2012
Decision Date09/24/2012
Product Code NVY 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
ADDING NEW LABELING SOFTWARE USED TO PRINT THE LABELS FOR VARIOUS DEVICES AND ACCESSORIES.
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