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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.
 
DeviceMODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE
Generic NameProgrammer, pacemaker
ApplicantSt. Jude Medical, Inc.
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP830045
Supplement NumberS082
Date Received08/02/2002
Decision Date08/13/2002
Withdrawal Date06/20/2007
Product Codes DXY KRG 
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 3307, V4.0A PROGRAMMING SOFTWARE AND THE MODEL 3160 ECG ADAPTER CABLE.
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