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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 NameCARELINK PROGRAMMER (MODEL 2090)/ANALYZER (MODEL 2290)
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pulse generator
Regulation Number870.3610
ApplicantMEDTRONIC VASCULAR
PMA NumberP890003
Supplement NumberS086
Date Received05/06/2005
Decision Date09/28/2005
Product Code
DXY[ Registered Establishments with DXY ]
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 for "software enhancements" to the model 9986 desktop/baseline operating system software (boss) for the carelink programmer and the model 8190 analyzer software for the model 2290 analyzer.
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