• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
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.
DeviceAED Plus and Fully Automatic AED Plus
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
269 & 271 MILL ROAD
Chelmsford, MA 01824
PMA NumberP160015
Date Received06/02/2016
Decision Date05/26/2017
Product Code MKJ 
Docket Number 17M-3372
Notice Date 08/07/2017
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015