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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 NamePHOENIX AND PARAGON PACEMAKERS
Classification Namepulse generator, permanent, implantable
Generic Nametiered therapy implantable defibrillator
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP830045
Supplement NumberS097
Date Received03/07/2006
Decision Date04/05/2006
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 3. 0 software for use on the model 3650 merlin patient care system which adds the support for the use of merlin with the victory, epic ii and frontier ii pulse generator families.
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