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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, CAPSUREFIX NOVUS LEAD AND CAPSUREFIX NOVUS MRI SURESCAN LEAD, VITATRON CRYSTALLINE ACTIVE FIXATIO
Generic NamePermanent defibrillator electrodes
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP930039
Supplement NumberS131
Date Received05/18/2015
Decision Date06/06/2015
Product Code NVY 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
UPDATES TO THE EQUIPMENT AND PROCESS FOR PLASMA-TREATED TUBING.
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