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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceAED 3 defibrillator
Generic Nameautomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantZOLL MEDICAL CORPORATION
269 & 271 mill road
chelmsford, MA 01824
PMA NumberP160015
Supplement NumberS001
Date Received08/18/2017
Decision Date02/28/2020
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the AED 3 Defibrillator.
Post-Approval StudyShow Report Schedule and Study Progress
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