Product code QBI
- Device name
- Acute Coronary Syndrome Event Detector
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Detect Acute Coronary Syndrome events and prompt the patient to seek medical attention.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P150009S012 | Guardian® System | Avertix Medical, Inc. | 2024-08-14 |
| P150009S013 | Guardian System | Avertix Medical, Inc. | 2024-06-21 |
| P150009S011 | Guardian System | Avertix Medical, Inc. | 2024-01-25 |
| P150009S009 | Guardian System | Avertix Medical, Inc. | 2023-08-10 |
| P150009S008 | AngelMed Guardian System | Avertix Medical, Inc. | 2022-09-21 |
| P150009S007 | AngelMed Guardian System | Avertix Medical, Inc. | 2022-05-19 |
| P150009S006 | AngelMed Guardian® System | Avertix Medical, Inc. | 2021-09-17 |
| P150009S002 | AngelMed Guardian System | Avertix Medical, Inc. | 2021-06-21 |
| P150009S005 | AngelMed Guardian System | Avertix Medical, Inc. | 2021-02-17 |
| P150009S004 | AngelMed Guardian System | Avertix Medical, Inc. | 2020-12-22 |
| P150009S003 | AngelMed Guardian System | Avertix Medical, Inc. | 2020-08-28 |
| P150009S001 | AngelMed Guardian System | Avertix Medical, Inc. | 2018-08-14 |
| P150009 | Guardian System | Avertix Medical, Inc. | 2018-04-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850012625162 | Guardian Programmer Model PROG-004 | Avertix Medical Inc. | 2025-03-05 |
| 00850012625155 | AngelMed Guardian EXD Model EXD-001 Battery | Avertix Medical Inc. | 2021-08-23 |
| 00850012625001 | AngelMed Guardian IMD Model AMSG3-E | Avertix Medical Inc. | 2021-03-03 |
| 00850012625063 | AngelMed Guardian Programmer Model PROG-003 | Avertix Medical Inc. | 2021-02-25 |
| 00850012625148 | AngelMed Guardian Programmer PROG-003 Carrying Case | Avertix Medical Inc. | 2021-02-25 |
| 00850012625131 | AngelMed Guardian Programmer Application User's Manual CD | Avertix Medical Inc. | 2021-02-25 |
| 00850012625124 | AngelMed Guardian Programmer USB Flash Drive | Avertix Medical Inc. | 2021-02-25 |
| 00850012625100 | AngelMed Guardian Programmer External Power Accessories | Avertix Medical Inc. | 2021-02-25 |
| 00850012625094 | AngelMed Guardian Programmer Serial Cable, 10 Foot | Avertix Medical Inc. | 2021-02-25 |
| 00850012625087 | AngelMed Guardian Programmer Serial Cable, 6 Foot | Avertix Medical Inc. | 2021-02-25 |
| 00850012625070 | AngelMed Guardian Programmer Wand EXD Model EXD-001 | Avertix Medical Inc. | 2021-02-25 |
| 10850012625152 | AngelMed Guardian EXD Model EXD-001 Battery, 10 Pack | Avertix Medical Inc. | 2021-02-25 |
| 00850012625056 | AngelMed Guardian EXD Lanyard | Avertix Medical Inc. | 2021-02-25 |
| 00850012625049 | AngelMed Guardian EXD Carrying Case | Avertix Medical Inc. | 2021-02-25 |
| 00850012625032 | AngelMed Guardian EXD Model EXD-001 | Avertix Medical Inc. | 2021-02-25 |
| 00850012625025 | AngelMed Guardian EXD Model EXD-001 | Avertix Medical Inc. | 2021-02-25 |
| 00850012625018 | AngelMed Guardian Torque Wrench | Avertix Medical Inc. | 2021-02-25 |
| 20850012625159 | AngelMed Guardian EXD Model EXD-001 Battery, 30 Pack | Avertix Medical Inc. | 2021-02-25 |