PMA P150009S012
- Device
- Guardian® System
- Applicant
- Avertix Medical, Inc.
- PMA number
- P150009
- Supplement
- S012
- Product code
- QBI
- Decision date
- 2024-08-14
- Classification
- Cardiovascular
- Generic name
- Acute coronary syndrome event detector
- Approval order statement
- approval of a new programmer for the Guardian System
Current openFDA PMA Record#
- Device
- Guardian® System
- Applicant
- Avertix Medical, Inc.
- PMA number
- P150009
- Supplement
- S012
- Product code
- QBI
- Generic name
- Acute coronary syndrome event detector
- Decision date
- 2024-08-14
- Decision code
- APPR
- Date received
- 2024-02-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval of a new programmer for the Guardian System