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 x series defibrillator function. The x series system is indicated for defibrillation on victims of cardiac arrest where there is apparent lack of circulation as indicated by:1) unconsciousness;2) absence of breathing; and3) absence of pulsethe x series system in the manual mode is indicated for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate. The x series system semiautomatic and manual mode is indicated for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving cpr, transportation, and definitive care are incorporated into a medically-approved patient care protocol. The x series system semiautomatic and manual mode is indicated for adult and pediatric patients. R series defibrillator functionthe r series system is indicated for defibrillation on victims of cardiac arrest where there is apparent lack of circulation as indicated by:1) unconsciousness;2) absence of breathing; and3) absence of pulse. The r series system in the manual mode is indicated for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate. The r series system semiautomatic and manual mode is indicated for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving cpr, transportation, and definitive care are incorporated into a medically-approved patient care protocol. The r series system semiautomatic and manual mode is indicated for adult and pediatric patients. Aed prothe aed pro system is indicated for use on victims of cardiac arrest with apparent lack of circulation as indicated by:1) unconsciousness;2) absence of breathing; and3) absence of pulse and other signs of circulation. The device is also indicated for use when ecg monitoring is indicated to evaluate the patient’s heart rate or ecg morphology. The aed pro system is indicated for adult and pediatric patients. Aed 3 blsthe zoll aed 3 system is indicated for use when a suspected cardiac arrest victim has an apparent lack of circulation as indicated by:1) unconsciousness;2) absence of breathing; and3) absence of pulse and other signs of circulation. The aed 3 system is indicated for adult and pediatric patients. ...
| Device | X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™ |
| Classification Name | Automated External Defibrillators (non-wearable) |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | ZOLL MEDICAL CORPORATION |
| Date Received | 2016-07-07 |
| Decision Date | 2017-12-27 |
| Notice Date | 2018-01-09 |
| PMA | P160022 |
| Supplement | S |
| Product Code | MKJ |
| Docket Number | 17M-7004 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ZOLL MEDICAL CORPORATION 269 & 271 Mill Road chelmsford, MA 01824-4105 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |