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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 SINGLE COIL DF4, ACTIVE FIXATION LEAD
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous,steroid eluting,quadripolar,active fixation, pace/sense ventricular lead
Applicant MEDTRONIC INC.
PMA NumberP920015
Supplement NumberS091
Date Received05/23/2012
Decision Date07/02/2012
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a change to the currently approved model 6935 sprint quattro secure s lead which is a single defibrillation coil is-1/df-1 active fixation lead for the creation of a new sprint quattro secure s single defibrillation coil df4 active fixation lead, model 6935m.
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