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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, SENSOLOG III, AND DIALOG II PACEMAKERS
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable cardiac pacemaker pulse generator
ApplicantST. JUDE MEDICAL
PMA NumberP880006
Supplement NumberS041
Date Received03/30/2006
Decision Date04/28/2006
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model 3307 v. 6. 1m programmer software.
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