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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, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD, VITATRON CRYSTALLINE ACTIVE FIX
Generic NamePermanent defibrillator electrodes
ApplicantMedtronic, Inc.
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP930039
Supplement NumberS134
Date Received06/19/2015
Decision Date07/14/2015
Product Code NVY 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ALTERNATE SUPPLIER OF A SILICONE COMPONENT AND FOR INSPECTIONS OFTHAT COMPONENT TO BE PERFORMED BY THE SUPPLIER FOR LOT RELEASE.
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