PMA P150009S008
- Device
- AngelMed Guardian System
- Applicant
- Avertix Medical, Inc.
- PMA number
- P150009
- Supplement
- S008
- Product code
- QBI
- Decision date
- 2022-09-21
- Generic name
- Acute coronary syndrome event detector
- Approval order statement
- Approval for service life expansion to 6 years.
Current openFDA PMA Record#
- Device
- AngelMed Guardian System
- Applicant
- Avertix Medical, Inc.
- PMA number
- P150009
- Supplement
- S008
- Product code
- QBI
- Generic name
- Acute coronary syndrome event detector
- Decision date
- 2022-09-21
- Decision code
- APPR
- Date received
- 2022-08-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for service life expansion to 6 years.