PMA P150009S009
- Device
- Guardian System
- Applicant
- Avertix Medical, Inc.
- PMA number
- P150009
- Supplement
- S009
- Product code
- QBI
- Decision date
- 2023-08-10
- Classification
- Cardiovascular
- Generic name
- Acute coronary syndrome event detector
- Approval order statement
- Approval for a trade name change to The Guardian System.
Current openFDA PMA Record#
- Device
- Guardian System
- Applicant
- Avertix Medical, Inc.
- PMA number
- P150009
- Supplement
- S009
- Product code
- QBI
- Generic name
- Acute coronary syndrome event detector
- Decision date
- 2023-08-10
- Decision code
- APPR
- Date received
- 2023-04-18
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a trade name change to The Guardian System.