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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.
 
DeviceCELERITY 2D 75, CELERITY 2D 85,CELERITY 3D 75, CELERITY 3D 85, CELERITY PILOT 75, CELERITY PILOT 85, COROX OTW-L 75-BP,
Generic Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
ApplicantBIOTRONIK, INC.
6024 jean road
lake oswego, OR 97035
PMA NumberP070008
Supplement NumberS064
Date Received04/29/2015
Decision Date01/28/2016
Product Code NKE 
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR AN ALTERNATIVE DRUG ELUTION METHOD FOR STEROID LEADS.
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