Guardian System
FDA premarket approval P150009 · decided 2018-04-09
Approval details
- PMA number
- P150009
- Trade name
- Guardian System
- Generic name
- Acute coronary syndrome event detector
- Applicant
- Avertix Medical, Inc.
- Date received
- 2015-02-23
- Decision date
- 2018-04-09
- Days to decision
- 1141 days
- Decision code
- APPR
- Product code
- QBI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Eatontown, NJ
- Statement
- Approval of the AngelMed Guardian System. This device is indicated for use in patients who have had prior acute coronary syndrome (ACS) events and who remain at high risk for recurrent ACS events.The Guardian System is indicated as an adjunct to patient recognized symptoms. The Guardian System detects potential ongoing ACS events, characterized by sustained ST segment changes, and alerts the patient to seek medical attention for those potential ACS events. A Guardian System alert is a more accur
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