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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 ADAPTA, VERSA AND SENSIA IMPLANTABLE PULSE GENERATOR AND MODEL SW003 APPLICATION SOFTWARE
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator programming software
Applicant MEDTRONIC INC.
PMA NumberP980035
Supplement NumberS073
Date Received05/29/2007
Decision Date05/13/2008
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the medtronic adapta/versa/ sensia implantable pacemakers (a/v/s pacemakers), model sw003 application software, and model 2490h medtronic carelink monitor and model 2491 ddma software.
Post-Approval StudyShow Report Schedule and Study Progress
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