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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.
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
PMA NumberP030054
Supplement NumberS088
Date Received05/12/2008
Decision Date06/24/2008
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for minor modifications and standardization of the ground connection, output flex, heat shield, and battery support for atla, atlas ii, convert, current, epic, epic ii, and promote crt-d and icd families.