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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 Name3500/3510 PROGRAMMER
Classification Nameprogrammer, pacemaker
Generic Namepacemaker programmer
Regulation Number870.3700
PMA NumberP880086
Supplement NumberS067
Date Received07/22/1999
Decision Date01/28/2000
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval is for the model 3304 programmer software for use with the model 3500 and 3510 programmers. The device is indicated for programming and interrogation of implanted st. Jude pacemakers.