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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePROGRAMMERS TO SUPPORT VARIOUS PACEMAKERS AND DEFIBRILLATORS
Generic NamePulse generator, permanent, implantable
ApplicantSt. Jude Medical, Inc.
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP830045
Supplement NumberS093
Date Received01/06/2006
Decision Date03/02/2006
Withdrawal Date06/20/2007
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODEL 3330 VERSION 1.2 SOFTWARE SUPPORTING THE MICRONY/REGENCY AND FRONTIER DEVICES ON THE MODEL 3650 MERLIN PROGRAMMER.
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