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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 NameTENDRIL LEADS
Classification Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Generic Namecardiovascular permanent pacemaker electrode
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP960013
Supplement NumberS052
Date Received08/31/2009
Decision Date01/20/2010
Product Code
NVN[ Registered Establishments with NVN ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new lead component supplier.
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