Premarket Approval (PMA)

Note: 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.

• Device: AED Plus and Fully Automatic AED Plus
• Generic Name: Automated external defibrillators (non-wearable)
• Regulation Number: 870.5310
• Applicant: Zoll Medical Corporation; 269 & 271 Mill Rd.; Chelsmford, MA 01824
• PMA Number: P160015
• Date Received: 06/02/2016
• Decision Date: 05/26/2017
• Product Code: MKJ
• Docket Number: 17M-3372
• Notice Date: 08/07/2017
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
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.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 ; S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S024 ; S026