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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 2090 MEDTRONIC CARELINK PROGRAMMER
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator programming software
Applicant MEDTRONIC INC.
PMA NumberP980035
Supplement NumberS138
Date Received06/17/2009
Decision Date07/28/2009
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for version 2. 2 of the model 9986 desktop/boss software for the medtronic carelink programmer.
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