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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 NameATLAS DR/VR IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namecardiac pacemaker
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP910023
Supplement NumberS058
Date Received11/29/2001
Decision Date12/21/2001
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 No
Approval Order Statement 
Approval for the atlas(tm) dr/vr (models v-240 and v-199) implantable cardioverter defibrillator system with model 3307 programmer software version 3. 1. These devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation, for automated treatment of life-threatening ventricular arrhythmias.
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