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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, ENPULSE E1/E2. KAPPA D/DR/VDD IPG'S
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator
Applicant MEDTRONIC INC.
PMA NumberP980035
Supplement NumberS391
Date Received08/20/2014
Decision Date11/07/2014
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 an update to your carelink and carelink express monitor firmware and software to improve the superimposed dual egm reporting.
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