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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMODEL 3510 PROGRAMMER/3303 SOFTWARE
Classification Nameprogrammer, pacemaker
Generic Namepacemaker programmer
Regulation Number870.3700
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP830045
Supplement NumberS064
Date Received03/24/1999
Decision Date04/21/1999
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
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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