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 design changes to achieve compliance with en 60601-1-2 (4th edition), pcb layout and parts changes, and minor mechanical changes to the speaker, printer, and display assemblies
| Device | Zoll R Series |
| Classification Name | Automated External Defibrillators (non-wearable) |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | ZOLL MEDICAL CORPORATION |
| Date Received | 2019-05-13 |
| Decision Date | 2019-08-09 |
| PMA | P160022 |
| Supplement | S011 |
| Product Code | MKJ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |