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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
ApplicantAvertix Medical Inc
40 Christopher Way
Suite 201
Eatontown, NJ 07724
PMA NumberP150009
Supplement NumberS003
Date Received07/28/2020
Decision Date08/28/2020
Product Code QBI 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Material change of the packaging lid for the AngelMed Guardian System.
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