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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 NameCADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM
Classification Nameimplantable pacemaker pulse-generator
Generic Nametranstelephonic follow-up/monitoring system
Regulation Number870.3610
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP910023
Supplement NumberS075
Date Received09/08/2004
Decision Date01/19/2005
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling modifications to describe the protocol and results from the definite clinical trial.
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