PMA P150009S004
- Device
- AngelMed Guardian System
- Applicant
- Avertix Medical, Inc.
- PMA number
- P150009
- Supplement
- S004
- Product code
- QBI
- Decision date
- 2020-12-22
- Generic name
- Acute coronary syndrome event detector
- Approval order statement
- component change the implantable and external device components of the AngelMed Guardian System
Current openFDA PMA Record#
- Device
- AngelMed Guardian System
- Applicant
- Avertix Medical, Inc.
- PMA number
- P150009
- Supplement
- S004
- Product code
- QBI
- Generic name
- Acute coronary syndrome event detector
- Decision date
- 2020-12-22
- Decision code
- OK30
- Date received
- 2020-12-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- component change the implantable and external device components of the AngelMed Guardian System