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. |
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Device | Guardian System |
Generic Name | Acute coronary syndrome event detector |
Applicant | Avertix Medical Inc 40 Christopher Way Suite 201 Eatontown, NJ 07724 |
PMA Number | P150009 |
Supplement Number | S011 |
Date Received | 10/05/2023 |
Decision Date | 01/25/2024 |
Product Code |
QBI |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement to replacing to the Angel Medical Systems, Inc. and the AngelMed Guardian System with the Avertix Medical, Inc. Guardian System without any modification of the device and manufacture process change. |
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