PMA P150009S006
- Device
- AngelMed Guardian® System
- Applicant
- Avertix Medical, Inc.
- PMA number
- P150009
- Supplement
- S006
- Product code
- QBI
- Decision date
- 2021-09-17
- Generic name
- Acute coronary syndrome event detector
- Approval order statement
- Additional supplier of capacitors used in the EXD system.
Current openFDA PMA Record#
- Device
- AngelMed Guardian® System
- Applicant
- Avertix Medical, Inc.
- PMA number
- P150009
- Supplement
- S006
- Product code
- QBI
- Generic name
- Acute coronary syndrome event detector
- Decision date
- 2021-09-17
- Decision code
- OK30
- Date received
- 2021-08-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional supplier of capacitors used in the EXD system.