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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 NameMODEL 6949 AND 6931 LEADS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous,steroid eluting,quadripolar,active fixation, pace/sense ventricular lead
Applicant MEDTRONIC INC.
PMA NumberP920015
Supplement NumberS029
Date Received11/06/2003
Decision Date06/08/2004
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the addition of a polyurethane overlay.
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