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.
| Device | AngelMed Guardian System |
| Generic Name | Acute Coronary Syndrome Event Detector |
| Applicant | ANGEL MEDICAL SYSTEMS INC.788 Shrewsbury Ave Suite 2200tinton Falls, NJ 07724 PMA NumberP150009 Supplement NumberS007 Date Received04/27/2022 Decision Date05/19/2022 Product Code QBI Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-04-27 |
| Decision Date | 2022-05-19 |
| PMA | P150009 |
| Supplement | S007 |
| Product Code | QBI |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ANGEL MEDICAL SYSTEMS INC. 788 Shrewsbury Ave Suite 2200 tinton Falls, NJ 07724 PMA NumberP150009 Supplement NumberS007 Date Received04/27/2022 Decision Date05/19/2022 Product Code QBI Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval Of The Revised Protocol For The AngelMed Guardian Post-approval Study. |
| 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 |