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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.
 
DeviceALIZEA and CELEA pacemakers, Remote monitoring software (RMS)
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMicroPort CRM USA Inc.
5640 Airline Road
Arlington, TN 38002
PMA NumberP950029
Supplement NumberS132
Date Received09/12/2022
Decision Date05/17/2023
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for upgrades to the following devices and associated software packages: ALIZEA and CELEA pacemakers, Orchestra Plus and SmartTouch programmer software modules, CPR4 Telemetry head accessory, and the Remote Monitoring System.
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