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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 NumberS188
Date Received08/19/2008
Decision Date09/04/2008
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 an alternate high voltage charging transformer and associated minor design changes to the hvpcb for the current and promote icds/crt-ds.
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