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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 NameFORTIFY AND VARIOUS FAMILIES OF CURRENT
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantST. JUDE MEDICAL
PMA NumberP030054
Supplement NumberS202
Date Received09/12/2011
Decision Date11/01/2011
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the introduction of the is4/df4 port plug accessory model ac-is4pp for use with all sjm df4 or is4 header ports.
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