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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceATLAS AND ATLAS+ IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Applicant
St. Jude Medical
15900 valley view ct.
sylmar, CA 91342-3577
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/material
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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