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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 Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Generic Namedrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantMEDTRONIC Inc.
PMA NumberP010015
Supplement NumberS070
Date Received06/17/2009
Decision Date07/28/2009
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
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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