This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval of the angelmed guardian system. This device is indicated for use in patients who have had prior acute coronary syndrome (acs) events and who remain at high risk for recurrent acs events. The guardian system is indicated as an adjunct to patient recognized symptoms. The guardian system detects potential ongoing acs events, characterized by sustained st segment changes, and alerts the patient to seek medical attention for those potential acs events. A guardian system alert is a more accurate predictor of acs events when compared to patient recognized symptoms alone and demonstrates a reduced rate over time of patient presentations without acs events (false positives) when compared to patient recognized symptoms alone. In the absence of symptoms, the guardian system may identify asymptomatic acs events and prompt the patient to seek medical attention.
| Device | ANGELMED GUARDIAN SYSTEM |
| Classification Name | Acute Coronary Syndrome Event Detector |
| Generic Name | Acute Coronary Syndrome Event Detector |
| Applicant | ANGEL MEDICAL SYSTEMS INC. |
| Date Received | 2015-02-23 |
| Decision Date | 2018-04-09 |
| Notice Date | 2018-04-11 |
| PMA | P150009 |
| Supplement | S |
| Product Code | QBI |
| Docket Number | 18M-1447 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ANGEL MEDICAL SYSTEMS INC. 788 Shrewsbury Ave Suite 2200 tinton Falls, NJ 07724 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150009 | Original Filing | |
| S008 | 2022-08-19 | Normal 180 Day Track No User Fee |
| S007 | 2022-04-27 | Normal 180 Day Track No User Fee |
| S006 | 2021-08-26 | 30-day Notice |
| S005 | 2021-01-19 | 30-day Notice |
| S004 | 2020-12-01 | 30-day Notice |
| S003 | 2020-07-28 | 30-day Notice |
| S002 | ||
| S001 | 2018-05-09 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 00850012625155 | P150009 | 000 |
| 00850012625018 | P150009 | 000 |
| 00850012625025 | P150009 | 000 |
| 00850012625032 | P150009 | 000 |
| 00850012625049 | P150009 | 000 |
| 00850012625056 | P150009 | 000 |
| 00850012625063 | P150009 | 000 |
| 00850012625070 | P150009 | 000 |
| 00850012625087 | P150009 | 000 |
| 00850012625094 | P150009 | 000 |
| 00850012625100 | P150009 | 000 |
| 00850012625124 | P150009 | 000 |
| 00850012625131 | P150009 | 000 |
| 00850012625148 | P150009 | 000 |
| 00850012625001 | P150009 | 000 |