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 |
Supplemental Filings
| 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 |
NIH GUDID Devices