Premarket Approval (PMA)

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.

• Device: AngelMed Guardian System
• Generic Name: Acute coronary syndrome event detector
• Applicant: CJ Healthtech Holdings, LLC; 125 Shore Ct.; Unit 208a; North Palm Beach, FL 33408
• PMA Number: P150009
• Supplement Number: S008
• Date Received: 08/19/2022
• Decision Date: 09/21/2022
• Product Code: QBI
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for service life expansion to 6 years.