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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMODEL 5076 CAPSURE FIX NOVUS ELECTRODE
Classification Namepermanent pacemaker electrode
Generic Namepacing lead
Regulation Number870.3680
ApplicantMEDTRONIC VASCULAR
PMA NumberP930039
Supplement NumberS016
Date Received07/02/2003
Decision Date08/25/2003
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for titanium nitride coating of the electrode helix tip.
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