PMA P150009S002
- Device
- AngelMed Guardian System
- Applicant
- Avertix Medical, Inc.
- Product code
- QBI
- Decision date
- 2021-06-21
- Generic name
- Acute coronary syndrome event detector
- Approval order statement
- Approval for changes to the design of the Implantable Medical Device resulting in the AMSG3-E model with a 1-year shelf life and a 3-year implanted life.
Current openFDA PMA Record#
- Device
- AngelMed Guardian System
- Applicant
- Avertix Medical, Inc.
- PMA number
- P150009
- Supplement
- S002
- Product code
- QBI
- Generic name
- Acute coronary syndrome event detector
- Decision date
- 2021-06-21
- Decision code
- APPR
- Date received
- 2019-01-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the design of the Implantable Medical Device resulting in the AMSG3-E model with a 1-year shelf life and a 3-year implanted life.