Guardian® System
FDA premarket approval P150009/S012 · decided 2024-08-14
Approval details
- PMA number
- P150009
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Guardian® System
- Generic name
- Acute coronary syndrome event detector
- Applicant
- Avertix Medical, Inc.
- Date received
- 2024-02-15
- Decision date
- 2024-08-14
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- QBI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Eatontown, NJ
- Statement
- approval of a new programmer for the Guardian System
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