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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.
 
DeviceQUICKFLEX U MODEL 1258T LEAD
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Generic Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Applicant
St. Jude Medical
15900 valley view ct.
sylmar, CA 91342-3577
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/material
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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