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.
Component change the implantable and external device components of the angelmed guardian system
| Device | AngelMed Guardian System |
| Generic Name | Acute Coronary Syndrome Event Detector |
| Applicant | ANGEL MEDICAL SYSTEMS INC. |
| Date Received | 2020-12-01 |
| Decision Date | 2020-12-22 |
| PMA | P150009 |
| Supplement | S004 |
| 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 | |
| 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 |