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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,VITATRON CRYSTALLINE LEAD
Classification Namepermanent defibrillator electrodes
Generic Namepermanent defibrillator electrodes
Applicant
Medtronic, Inc.
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP930039
Supplement NumberS102
Date Received12/24/2013
Decision Date01/16/2014
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
USE OF THE INCOMING INSPECTION (RECEIVING BATCH ON PURCHASE ORDER) WORK FLOW WITH SAP QUALITY MANAGEMENT (QM) MODULE.
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