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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
Generic NamePermanent defibrillator electrodes
ApplicantMedtronic, Inc.
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP930039
Supplement NumberS110
Date Received06/16/2014
Decision Date07/08/2014
Product Code NVY 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
ADD A HELIX LINEARITY INSPECTION AT THE FINAL FUNCTIONAL INSPECTION AND A HELIX LINEARITY FIXTURE TO FACILITATE THIS LINEARITY INSPECTION.
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