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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 NameMARQUIS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber icds
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS023
Date Received10/15/2001
Decision Date03/01/2002
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
Recalls CDRH Recalls
Approval Order Statement 
Approval for medtronic model 7274 marquis dr dual chamber implantable cardioverter defibrillator system with model 9966 (marquis dr) application software, model 9990 desktop software, model 9322 patient magnet, and model 9767/9767l telemetry programming head (telemetry b). The device, as modified, will be marketed under the trade name medtronic model 7274 marquis dr dual chamber implantable cardioverter defibrillator system and is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
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