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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.
 
DeviceSELOX JT 45 /JT53; ST53/ST60;TILDA R45, R53,R60; SAFIO S53, S60; TILDA JT45,53, TILDA T53,60; DRUG ELUTING PERMANENT RIG
Generic NamePulse generator, permanent, implantable
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS147
Date Received02/04/2015
Decision Date02/20/2015
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
REPLACE FINISHED STEROID ELUTING LEADS WITH LEAD DUMMIES FOR THE PARTICULATE MATTER TESTING.
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