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.
New equipment used in the flex printed circuit board manufacturing line at a supplier
| Device | X Series, R Series, and AED Pro |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | ZOLL MEDICAL CORPORATION |
| Date Received | 2020-11-24 |
| Decision Date | 2020-12-07 |
| PMA | P160022 |
| Supplement | S023 |
| 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 01824-4105 |
| 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 |