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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.
 
DeviceAPS III MODEL 3500 PROGRAMMER
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantSt. Jude Medical, Inc.
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP830045
Supplement NumberS054
Date Received07/31/1997
Decision Date10/07/1997
Withdrawal Date06/20/2007
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the APS II Model 3500 Programmer with Mdoel 3302 Software.
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