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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 NameADAPTA, ADVISA, AT500, ENPULSE, ENRHYTHM, KAPPA 600, KAPPA 650, KAPPA 700, KAPPA 800, KAPPA 900, RELIA
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator
Applicant MEDTRONIC INC.
PMA NumberP980035
Supplement NumberS268
Date Received04/04/2012
Decision Date04/25/2012
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software updates and minor software enhancements to medtronic model 9986 desktop/ baseline operating system software (boss) version 2. 6 for the medtronic model 2090 carelink programmer.
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