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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
Generic Namepacing lead
Applicant MEDTRONIC INC.
PMA NumberP030036
Supplement NumberS004
Date Received12/31/2007
Decision Date03/30/2011
Product Code
NVN[ Registered Establishments with NVN ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Review Memo Review Memo
Approval Order Statement 
Approval for improvements to the chemistry, manufacturing , and controls (cmc) and elution methods and specifications for the drug coating on selectsecure model 3830 leads.
Approval Order Approval Order
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