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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 NameREGENCY PACEMAKERS
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable cardiac pacemaker pulse generator
ApplicantST. JUDE MEDICAL
PMA NumberP880006
Supplement NumberS040
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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