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 NumberS008 Date Received08/19/2022 Decision Date09/21/2022 Product Code QBI Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-08-19 |
| Decision Date | 2022-09-21 |
| PMA | P150009 |
| Supplement | S008 |
| Product Code | QBI |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ANGEL MEDICAL SYSTEMS INC. 788 Shrewsbury Ave Suite 2200 tinton Falls, NJ 07724 PMA NumberP150009 Supplement NumberS008 Date Received08/19/2022 Decision Date09/21/2022 Product Code QBI Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For Service Life Expansion To 6 Years. |
| 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 |