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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 NameFRONTIER, FRONTIER II, ANTHEM FAMILIES OF CRTP'S
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantST. JUDE MEDICAL
PMA NumberP030035
Supplement NumberS094
Date Received02/22/2012
Decision Date04/13/2012
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for implementing palladium-iridium (pd-ir) alloy wire as an alternate to the existing platinum-iridium (pt-ir) alloy feedthru wire in st. Jude medical high and low voltage pulse generators.
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