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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.
 
DeviceVARIOUS MODELS OF PACEMAKERS
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantSt. Jude Medical, Inc.
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP820018
Supplement NumberS077
Date Received06/07/2006
Decision Date07/11/2006
Withdrawal Date06/20/2007
Product Code LWP 
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 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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