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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 3830
Generic NamePermanent defibrillator electrodes
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP030036
Supplement NumberS003
Date Received02/26/2007
Decision Date10/21/2008
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 A CHANGE TO THE 1 CC SYRINGE USED TO MANUALLY MEASURE APPLICATION WITH A MANUALLY OPERATED AUTOMATED DISPENSER AND TO MODIFY THE DIMENSIONS OF THE FILLING TUBE TO PREVENT OVER-FILL OF THE PRECISELY MEASURED STEROID SOLUTION WITHIN THE FILLING TUBE.
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