Guardian System
FDA premarket approval P150009/S011 · decided 2024-01-25
Approval details
- PMA number
- P150009
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Guardian System
- Generic name
- Acute coronary syndrome event detector
- Applicant
- Avertix Medical, Inc.
- Date received
- 2023-10-05
- Decision date
- 2024-01-25
- Days to decision
- 112 days
- Decision code
- APPR
- Product code
- QBI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Eatontown, NJ
- Statement
- to replacing to the Angel Medical Systems, Inc. and the AngelMed Guardian System with the Avertix Medical, Inc. Guardian System without any modification of the device and manufacture process change.
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