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.
Approval for an additional rework process on the replacement of the surface mount capacitors utilized on the aed plus device printed circuit board assembly (pcba)
| Device | AED Plus |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | ZOLL MEDICAL CORPORATION |
| Date Received | 2020-01-03 |
| Decision Date | 2020-01-24 |
| PMA | P160015 |
| Supplement | S003 |
| Product Code | MKJ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ZOLL MEDICAL CORPORATION 269 & 271 Mill Road chelmsford, MA 01824 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160015 | Original Filing | |
| S014 | 2022-05-20 | 30-day Notice |
| S013 | 2022-02-23 | 30-day Notice |
| S012 | 2021-08-06 | 30-day Notice |
| S011 | 2021-02-24 | 30-day Notice |
| S010 | 2021-02-16 | 30-day Notice |
| S009 | 2020-12-18 | 30-day Notice |
| S008 | 2020-12-16 | 30-day Notice |
| S007 | 2020-12-15 | 30-day Notice |
| S006 | 2020-09-28 | 30-day Notice |
| S005 | ||
| S004 | 2020-03-27 | Normal 180 Day Track No User Fee |
| S003 | 2020-01-03 | 30-day Notice |
| S002 | 2018-08-23 | 135 Review Track For 30-day Notice |
| S001 |