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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,VERSA,SENSIA,ADVISA DR,ADVISA DR MRI,ENPULSE E1,ENPULSE E2,ENRHYTHM,KAPPA D(KAPPA 700),KAPPA D (KAPPA 900) IPG, K
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator
Applicant MEDTRONIC INC.
PMA NumberP980035
Supplement NumberS338
Date Received07/08/2013
Decision Date09/27/2013
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for the mycarelink patient monitor models 24950 (software version r50), 24951 (software version r50. A. 1), and 24955 (software version v29) to be used with the devices.
Approval Order Approval Order
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