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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 NameCAPSUREFIX MODELS 4568, 4067, 5068, 5067, 5568; SUREFIX MODEL 5072; SPRINT MODELS 6945, 6943; SPRINT QUATTRO MODEL 6947
Classification Namepermanent defibrillator electrodes
Generic Namepacing lead
ApplicantMEDTRONIC VASCULAR
PMA NumberP930039
Supplement NumberS020
Date Received09/10/2004
Decision Date02/07/2006
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for change to the monolithic controlled-released device (mcrd) and addition of dexamethasone sodium phosphate (dsp) to the distal tip of the leads previously listed.
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