PMA P150009S007
- Device
- AngelMed Guardian System
- Applicant
- Avertix Medical, Inc.
- PMA number
- P150009
- Supplement
- S007
- Product code
- QBI
- Decision date
- 2022-05-19
- Generic name
- Acute coronary syndrome event detector
- Approval order statement
- Approval of the revised protocol for the AngelMed Guardian post-approval study.
Current openFDA PMA Record#
- Device
- AngelMed Guardian System
- Applicant
- Avertix Medical, Inc.
- PMA number
- P150009
- Supplement
- S007
- Product code
- QBI
- Generic name
- Acute coronary syndrome event detector
- Decision date
- 2022-05-19
- Decision code
- APPR
- Date received
- 2022-04-27
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the AngelMed Guardian post-approval study.