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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMEDTRONIC SELECTSECURE LEAD MODEL 3830
Generic NameDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP030036
Supplement NumberS040
Date Received02/06/2012
Decision Date11/02/2012
Product Code NVN 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR IMPROVEMENTS TO THE SELECTSECURE MODEL 3830 LEAD DRUG METHODS AND SPECIFICATIONS.
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