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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 NameQUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedual chamber implantable cardioverter defibrillator with biventricular pacing
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP030054
Supplement NumberS018
Date Received11/07/2005
Decision Date02/15/2006
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for a modification to the quicksite xl model 1058t left ventricular pacing lead to increase the peak-to-peak amplitude of then distal s-curve height to 16 mm. The device, as modified, will be marketed under the trade name quicksite xl model 1058t left ventricular pacing lead and is indicated for application as part of a st. Jude medical biventricular system.
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