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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 NameQUICKFLEX U MODEL 1258T LEAD
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantST. JUDE MEDICAL
PMA NumberP030054
Supplement NumberS130
Date Received07/16/2009
Decision Date05/10/2010
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Clinical Trials NCT00763698
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Review Memo Review Memo
Approval Order Statement 
Approval for the quickflex µ model 1258tleft ventricular lead.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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