This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the aed plus and fully automatic aed plus. These devices are indicated for use when a suspected cardiac arrest victim has an apparent lack of circulation as indicated by:1) unconsciousness;2) absence of normal breathing; and3) absence of a pulse or signs of circulationthese devices are intended for use by personnel who have been trained in their operation. Users should have received training in basic life support/aed, advanced life support or a physician-authorized emergency medical response training program. When a victim is less than 8 years of age, or weighs less than 55 lbs. (25kg), the zoll aed plus® and fully automatic aed plus® should be used with the zoll aed plus and fully automatic aed plus® pediatric electrodes. Therapy should not be delayed to determine the patients exact age or weight.
| Device | AED Plus and Fully Automatic AED Plus |
| Classification Name | Automated External Defibrillators (non-wearable) |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | ZOLL MEDICAL CORPORATION |
| Date Received | 2016-06-02 |
| Decision Date | 2017-05-26 |
| Notice Date | 2017-08-07 |
| PMA | P160015 |
| Supplement | S |
| Product Code | MKJ |
| Docket Number | 17M-3372 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ZOLL MEDICAL CORPORATION 269 & 271 Mill Road chelmsford, MA 01824 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |