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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/CADET/CONTOUR/II/MD/ATLAS II/MD/+/PROFILE II/MD/PHOTON/PHOTON MICRO/CURRENT/+/EPIC II/+/CONVERT
Classification Namepulse generator, permanent, implantable
Generic Nametranstelephonic follow-up/monitoring system
ApplicantST. JUDE MEDICAL
PMA NumberP910023
Supplement NumberS227
Date Received11/25/2009
Decision Date05/11/2011
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site at st. Jude medical puerto rico llc located in arecibo, puerto rico.
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