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 |