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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 NumberS004
Date Received12/31/2007
Decision Date03/30/2011
Product Code NVN 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Review MemoReview 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 OrderApproval Order
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