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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 FAMILY OF ICDS
Classification Namepulse generator, permanent, implantable
Generic Nametranstelephonic follow-up/monitoring system
ApplicantST. JUDE MEDICAL
PMA NumberP910023
Supplement NumberS202
Date Received02/17/2009
Decision Date03/23/2009
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the modifications of the c64 ic (version p) for the epic ii / atlas ii platform of icds, and sio2 ic (version g) for the epic+ / atlas+ and epic ii / atlas ii platform of icds.
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