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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.
 
DeviceAVEIR™ Patient Transmitter (model, LSRM01), AVEIR™ Patient Transmitter Software (model, LSRM1000 v 1.0), AVEIR Patient T
Generic NamePacemaker/icd/crt non-implanted components
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP150035
Supplement NumberS028
Date Received06/27/2025
Decision Date09/24/2025
Product Code OSR 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for the AVEIR Remote Care System ECG Feature
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