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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 MODEL 1156T AND XL MODEL 1158T LEFT VENTRICULAR PACING LEADS
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedual chamber implantable cardioverter defibrillator with biventricular pacing
ApplicantST. JUDE MEDICAL
PMA NumberP030054
Supplement NumberS049
Date Received02/06/2007
Decision Date07/25/2007
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for distal tip modifications to the quicksite lead family to reduce the length of rigid sections and increase lead flexibility. The device, as modified, will be marketed under the trade name quickflex model 1156t and xl model 1158t left ventricular pacing leads. Quickflex leads are 6 french, transvenous, steroid eluting, bipolar, is-1 compatible, s-shaped curve, passive fixation leads intended for permanent sensing and pacing of the left ventricle when used with a compatible st. Jude medical?s biventricular system.
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