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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 NameSPRINT QUATTRO STEROID-ELUTING LEAD MODEL 6944
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous,steroid eluting,quadripolar,active fixation, pace/sense ventricular lead
Applicant MEDTRONIC INC.
PMA NumberP920015
Supplement NumberS028
Date Received04/28/2003
Decision Date07/21/2003
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for addition of the dexamethasone sodium phosphate (dsp) steroid to the lead tip.
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