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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 NameVARIOUS MODELS OF PACEMAKERS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namepacemaker programmer
ApplicantST. JUDE MEDICAL
PMA NumberP820018
Supplement NumberS077
Date Received06/07/2006
Decision Date07/11/2006
Product Code
LWP[ Registered Establishments with LWP ]
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 v4. 0 software for use on the model 3650 merlin patient care system and the model 3307 v6. 1. 1m software for use on the model 3510 programmer.
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