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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.
DeviceAngelMed Guardian System
Generic Nameacute coronary syndrome event detector
788 shrewsbury ave suite 2200
tinton falls, NJ 07724
PMA NumberP150009
Supplement NumberS002
Date Received01/28/2019
Decision Date06/21/2021
Product Code QBI 
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 changes to the design of the Implantable Medical Device resulting in the AMSG3-E model with a 1-year shelf life and a 3-year implanted life.