Identity
- Trade Name
- Guardian System FDA PMA
- Generic Name
- Acute coronary syndrome event detector FDA PMA
Identifiers
- PMA Number
- P150009 FDA PMA
- FDA Product Code
- QBI FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The AngelMed Guardian System is a Class III Acute Coronary Syndrome Event Detector, designed to identify potential ongoing acute coronary syndrome (ACS) events. It detects sustained ST segment changes, serving as an adjunct to patient-recognized symptoms to alert users of possible ACS events, including asymptomatic cases.
This device is supplied as a medical alert system and operates as a single-use or reusable diagnostic aid, depending on configuration. It requires FDA Premarket Approval (PMA P150009) and is intended for high-risk patients with prior ACS events. Storage and handling follow standard medical device protocols, with no specific sterility requirements noted beyond typical clinical use guidelines.
Frequently asked questions
Who is the Guardian System intended for, and how does it help patients?
The Guardian System is designed for high-risk patients who have experienced prior acute coronary syndrome (ACS) events and remain at elevated risk for recurrent episodes. It acts as an adjunct to patient-recognized symptoms by detecting sustained ST segment changes, which may indicate ongoing ACS—even in asymptomatic cases. This helps alert patients to seek timely medical attention, improving the accuracy of ACS detection compared to symptoms alone and reducing unnecessary emergency visits.
Is the Guardian System meant for single-use or can it be reused, and how should it be handled?
The Guardian System can be configured for either single-use or reusable applications, depending on the specific setup. Since it is not classified as a sterile device, standard medical device handling protocols apply. Storage should follow typical clinical guidelines to ensure proper functionality, though no additional sterility requirements are specified beyond routine use.
What regulatory approval does the Guardian System hold, and how does that affect its use?
The Guardian System holds FDA Premarket Approval (PMA P150009), meaning it has undergone rigorous review to demonstrate safety and effectiveness for its intended purpose. This approval confirms its use as an adjunct to patient symptoms for detecting potential ACS events in high-risk patients, including asymptomatic cases. Clinicians and patients can rely on this approval when considering its integration into patient monitoring protocols.
How does the Guardian System differ from relying solely on a patient’s symptoms to identify ACS?
The Guardian System improves ACS detection accuracy by identifying sustained ST segment changes, which may not always be recognized by patients alone. Studies show it reduces false positives over time compared to symptom-based alerts, meaning fewer unnecessary emergency visits while still capturing asymptomatic ACS events. This makes it a more reliable tool for high-risk patients prone to recurrent ACS.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P150009 | Class III | Active |
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Manufacturer
- Manufacturer
- Avertix Medical Inc.
- FDA Applicant
- Avertix Medical, Inc.
Sources (1)
- FDA PMA P150009 24 fields · synced Sep 18, 2026