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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 FAMILY OF LEADS-MODELS 1056K, 1056T AND 1058T & QUICKFLEX FAMILY OF LEADS-MODELS 1156T AND 1158T
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantST. JUDE MEDICAL
PMA NumberP030054
Supplement NumberS083
Date Received03/10/2008
Decision Date04/23/2008
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for changes to the stylets, packaging and labeling for the quicksite and quickflex lead families.
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