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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 3150 PACING SYSTEM ANALYZER WAND AND THE MODEL 3307 V4.7 PROGRAMMER SOFTWARE FOR USE WITH MODEL 3510 PROGRAMMERS
Classification Nameprogrammer, pacemaker
Generic Nametiered therapy implantable defibrillator
Regulation Number870.3700
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP880086
Supplement NumberS100
Date Received05/17/2004
Decision Date07/21/2004
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model 3150 pacing system analyzer wand and the model 3307 v4. 7 programmer software for use with model 3510 programmers.
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