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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, AVEIR™ Patient Transmitter Software, AVEIR™ Patient Trasmitter Wired Electrodes, Merlin.net™
Generic NameLeadless pacemaker
Regulation Number870.3610
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP150035
Supplement NumberS007
Date Received02/13/2024
Decision Date10/11/2024
Product Code PNJ 
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 designed to provide remote monitoring support for patients implanted with an Aveir Leadless Pacemaker(s).
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