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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAssurity MRI, Endurity MRI family of Pacemakers
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
ApplicantAbbott Medical
15900 valley view court
sylmar, CA 91335
PMA NumberP140033
Supplement NumberS008
Date Received05/17/2017
Decision Date08/23/2017
Product Code DXY 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
Approval for cybersecurity updates to the firmware of low voltage devices, cybersecurity updates to the clinician programmer, and updates to the programmer and Merlin.net server to detect rapid battery depletion in high voltage devices.
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