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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 SECURE S SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD MODEL 6935
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous,steroid eluting,quadripolar,active fixation, pace/sense ventricular lead
Applicant MEDTRONIC INC.
PMA NumberP920015
Supplement NumberS039
Date Received03/03/2008
Decision Date04/29/2008
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
Recalls CDRH Recalls
Approval Order Statement 
Approval for a single-defibrillation-coil version of the fda approved sprint quattro model 6947 dual-defibrillation ?coil active-fixation right ventricular lead. The device, as modified, will be marketed under te trade name sprint quattro model 6935 lead and is intended for long-term use in the right ventricle for patients indicated for implantable cardioverter defibrillators.
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