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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 NameMEDTRONIC SPRINT QUATTRO SECURE LEAD MODEL 6947M
Classification Namepermanent defibrillator electrodes
Generic Nametransvenous,steroid eluting,quadripolar,active fixation, pace/sense ventricular lead
Applicant MEDTRONIC INC.
PMA NumberP920015
Supplement NumberS055
Date Received12/04/2009
Decision Date01/09/2012
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Review Memo Review Memo
Approval Order Statement 
Approval for the df4 connector system, which is comprised of the icd, crt-d and defibrillation lead devices for the devices.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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