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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameVARIOUS FAMILIES/MODELS OF CELERITY CRT PACING LEADS
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantBIOTRONIK, INC.
PMA NumberP070008
Supplement NumberS027
Date Received10/03/2011
Decision Date12/02/2011
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for additional trade names for the selox, setrox and corox families of pacing leads.
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