AngelMed Guardian System
FDA premarket approval P150009/S001 · decided 2018-08-14
Approval details
- PMA number
- P150009
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- AngelMed Guardian System
- Generic name
- Acute coronary syndrome event detector
- Applicant
- Avertix Medical, Inc.
- Date received
- 2018-05-09
- Decision date
- 2018-08-14
- Days to decision
- 97 days
- Decision code
- APPR
- Product code
- QBI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Eatontown, NJ
- Statement
- Approval for the AngelMed Guardian System. This device is an implantable cardiac monitor with patient alerting capability and an additional external alarm device. The 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,
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