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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 3510 PROGRAMMER/3303 SOFTWARE
Generic NameProgrammer, pacemaker
Regulation Number870.3700
ApplicantSt. Jude Medical, Inc.
15900 VALLEY VIEW Court
SYLMAR, CA 91342
PMA NumberP830045
Supplement NumberS064
Date Received03/24/1999
Decision Date04/21/1999
Withdrawal Date 06/20/2007
Product Code KRG 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Model 3510 Programmer with Model 3303 version 1.02 Software. The device, as modified, will be marketed under the trade name the Model 3510 Programmer with Model 3303 version 1.02 Software and is indicated for the programming and interrogation of implanted St. Jude Pacemakers.
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