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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 NamePARAGON/PHOENIX FAMILY OF PACEMAKERS
Classification Namepulse generator, permanent, implantable
Generic Nametiered therapy implantable defibrillator
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP830045
Supplement NumberS104
Date Received10/23/2006
Decision Date11/30/2006
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model 3330 version 5. 2 software for use on the model 3650 merlin patient care system and the model 3307 version 6. 3. 2 software for use on the model 3510 and 3500 programmers.
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