|
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 | S009 |
Date Received | 04/18/2023 |
Decision Date | 08/10/2023 |
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 |
Approval Order Statement Approval for a trade name change to The Guardian System. |