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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 OF LEFT HEART LEADS
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantST. JUDE MEDICAL
PMA NumberP030054
Supplement NumberS158
Date Received06/30/2010
Decision Date08/05/2010
Product Code
OJX[ Registered Establishments with OJX ]
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 a modified connector ring on quickflex model 1156t and 1158t left heart leads.
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