PMA P150009S005
- Device
- AngelMed Guardian System
- Applicant
- Avertix Medical, Inc.
- PMA number
- P150009
- Supplement
- S005
- Product code
- QBI
- Decision date
- 2021-02-17
- Generic name
- Acute coronary syndrome event detector
- Approval order statement
- New component manufacturer for the external patient electronics system.
Current openFDA PMA Record#
- Device
- AngelMed Guardian System
- Applicant
- Avertix Medical, Inc.
- PMA number
- P150009
- Supplement
- S005
- Product code
- QBI
- Generic name
- Acute coronary syndrome event detector
- Decision date
- 2021-02-17
- Decision code
- OK30
- Date received
- 2021-01-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New component manufacturer for the external patient electronics system.