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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 Name1258T AND 1458Q FAMILY OF LEADS
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantST. JUDE MEDICAL
PMA NumberP030054
Supplement NumberS246
Date Received07/09/2013
Decision Date11/14/2013
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a modification to the weld shaft component on 1258t and 1458q lead families.
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