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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 MODEL 6944 LEAD
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namepacer cardioverter defibrillator
Applicant MEDTRONIC INC.
PMA NumberP920015
Supplement NumberS017
Date Received06/20/2000
Decision Date12/15/2000
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the medtronic(r) sprint(tm) quattro(tm) model 6944 lead which is intended for single long-term use in the right ventricle. This lead has application for patients in which implantable cardioverter defibrillators are indicated.
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