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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 NameSJM ACTIVE & PASSIVE LEADS
Classification Namepermanent defibrillator electrodes
Generic Namecardiovascular permanent pacemaker electrode
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP960030
Supplement NumberS015
Date Received02/26/2007
Decision Date11/19/2009
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a minor process change to an sjm vendor in the manufacture of sjm active and passive leads.
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