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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
ApplicantCJ Healthtech Holdings, LLC
125 Shore Ct.
Unit 208a
North Palm Beach, FL 33408
PMA NumberP150009
Supplement NumberS004
Date Received12/01/2020
Decision Date12/22/2020
Product Code QBI 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
component change the implantable and external device components of the AngelMed Guardian System
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