|
Device | AngelMed 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 | S007 |
Date Received | 04/27/2022 |
Decision Date | 05/19/2022 |
Product Code |
QBI |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the revised protocol for the AngelMed Guardian post-approval study. |