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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 FAMILY OF LEFT HEART LEADS
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantST. JUDE MEDICAL
PMA NumberP030054
Supplement NumberS170
Date Received08/20/2010
Decision Date09/24/2010
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 an increase in inner diameter of the stylet stop feature of the electrode component of the device.
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