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 of the revised protocol for the post-approval study (pas). The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p160022
| Device | X Series Advanced s |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | ZOLL MEDICAL CORPORATION |
| Date Received | 2021-04-23 |
| Decision Date | 2021-05-19 |
| PMA | P160022 |
| Supplement | S028 |
| Product Code | MKJ |
| 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 | ZOLL MEDICAL CORPORATION 269 & 271 Mill Road chelmsford, MA 01824-4105 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160022 | Original Filing | |
| S028 | 2021-04-23 | Normal 180 Day Track No User Fee |
| S027 | 2021-03-15 | 30-day Notice |
| S026 | 2021-02-24 | 30-day Notice |
| S025 | 2020-12-21 | 30-day Notice |
| S024 | 2020-12-17 | 30-day Notice |
| S023 | 2020-11-24 | 30-day Notice |
| S022 | 2020-09-16 | 30-day Notice |
| S021 | 2020-09-14 | 30-day Notice |
| S020 | ||
| S019 | ||
| S018 | 2020-05-29 | 30-day Notice |
| S017 | ||
| S016 | ||
| S015 | ||
| S014 | ||
| S013 | ||
| S012 | 2019-07-26 | 30-day Notice |
| S011 | 2019-05-13 | Real-time Process |
| S010 | 2019-04-08 | Real-time Process |
| S009 | 2019-03-19 | 30-day Notice |
| S008 | ||
| S007 | 2018-08-10 | Real-time Process |
| S006 | 2018-06-07 | Real-time Process |
| S005 | 2018-06-07 | Real-time Process |
| S004 | 2018-05-18 | Real-time Process |
| S003 | 2018-04-30 | 30-day Notice |
| S002 | 2018-04-30 | 30-day Notice |
| S001 | 2018-01-16 | Real-time Process |