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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.
 
DeviceCAPSUREFIX NOVUS, LEAD AND CAPSUREFIX , NOVUS MRI SURESCAN AND VITATRON CRYSTALLINE LEADS
Generic NamePermanent defibrillator electrodes
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP930039
Supplement NumberS123
Date Received12/08/2014
Decision Date03/18/2016
Product Code NVY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a design change to the lead helix electrode and a manufacturing site change and the related update to analytical methods and tightened specifications proposed for drug related elements of the medical devices.
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