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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 WITH SOFTWARE MODEL 3303 V1.03
Classification Nameprogrammer, pacemaker
Generic Namepacemaker programmer
Regulation Number870.3700
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP880086
Supplement NumberS063
Date Received07/02/1999
Decision Date07/21/1999
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 modifications to the model 3303 v1. 03 programmer software for use with the models 3500/3510 programmers.
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