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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 NameMEDTRONIC MODEL 2090 & 2090X CARELINK PROGRAMMER
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator
Applicant MEDTRONIC INC.
PMA NumberP890003
Supplement NumberS190
Date Received04/15/2010
Decision Date05/14/2010
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the antenna support, manufacturing process changes related to the antenna support change, and changes to an antenna test.
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