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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 NameMEDTRONIC SELECTSECURE LEAD MODEL 3830
Classification Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Applicant MEDTRONIC INC.
PMA NumberP030036
Supplement NumberS040
Date Received02/06/2012
Decision Date11/02/2012
Product Code
NVN[ Registered Establishments with NVN ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for improvements to the selectsecure model 3830 lead drug methods and specifications.
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