This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
A new component manufacturer for the external patient electronics system
| Device | AngelMed Guardian System |
| Generic Name | Acute Coronary Syndrome Event Detector |
| Applicant | ANGEL MEDICAL SYSTEMS INC. |
| Date Received | 2021-01-19 |
| Decision Date | 2021-02-17 |
| PMA | P150009 |
| Supplement | S005 |
| Product Code | QBI |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ANGEL MEDICAL SYSTEMS INC. 788 Shrewsbury Ave Suite 2200 tinton Falls, NJ 07724 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150009 | Original Filing | |
| 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 |