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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 NameCOROX OTW 75-UP STEROID LEAD, COROS OTW 85-UP STEROID LEAD
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantBIOTRONIK, INC.
PMA NumberP050023
Supplement NumberS056
Date Received10/12/2012
Decision Date01/11/2013
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for updating the labeling for the corox family over the wire (otw) left ventricular (lv) pacing lead to reflect the findings of the corox otw steroid lv monitoring (cosmo) post-approval study.
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