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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceQUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP030054
Supplement NumberS018
Date Received11/07/2005
Decision Date02/15/2006
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH 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.
Post-Approval StudyShow Report Schedule and Study Progress
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