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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/BR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND MODEL 3307 V.4.5A SOFTWARE
Classification Nameimplantable pacemaker pulse-generator
Generic Nametiered therapy implantable defibrillator
Regulation Number870.3610
ApplicantST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
PMA NumberP910023
Supplement NumberS069
Date Received09/11/2003
Decision Date10/17/2003
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the epic+ icds to include higher energy output, software modifications, and a different header type. The device, as modified, will be marketed under the trade name atlas+ dr/vr implantable cardioverter defibrillators, models v-242, v-243, v-193 and v-193c, epic+ models v-233, v-239 and v196, and model 3307 v. 4. 5a software, and is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Af suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above icd indications.
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