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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.
 
DeviceSELECTSECURE LEAD
Generic NamePermanent defibrillator electrodes
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP030036
Supplement NumberS009
Date Received08/22/2008
Decision Date02/25/2009
Product Code NVY 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING CHANGES: 1) A CHANGE IN THE MANUFACTURING FACILITY FOR THE DRUG VIAL FILLING PROCESS; 2) THE ADDITION OF A CONTRACT LABORATORY FOR DRUG RELEASE TESTING; AND 3) A CHANGE IN A QUALITY CONTROL TEST USED TO DETERMINE A SPECIFIC ATTRIBUTE OF AN INCOMING RAW MATERIAL.
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