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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 AND ATLAS+ IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedual chamber implantable cardioverter defibrillator with biventricular pacing
ApplicantST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
PMA NumberP030054
Supplement NumberS007
Date Received04/12/2005
Decision Date06/17/2005
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the icd firmware version 6. 6. 7 for epic models v-233, v-239, v-239t, v-196, v-196t, v-338, v-337, epic plus models v-236, v-196, atlas and atlas plus models v-242, v243, v-193, v-193c, v340, v-343; and model 3307 programmer software version 4. 8. 5.
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