Guardian System
FDA premarket approval P150009/S009 · decided 2023-08-10
Approval details
- PMA number
- P150009
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Guardian System
- Generic name
- Acute coronary syndrome event detector
- Applicant
- Avertix Medical, Inc.
- Date received
- 2023-04-18
- Decision date
- 2023-08-10
- Days to decision
- 114 days
- Decision code
- APPR
- Product code
- QBI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Eatontown, NJ
- Statement
- Approval for a trade name change to The Guardian System.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.