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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 BLS
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantZOLL MEDICAL CORPORATION
269 & 271 MILL ROAD
CHELMSFORD, MA 01824-4105
PMA NumberP160022
Supplement NumberS021
Date Received09/14/2020
Decision Date09/17/2020
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
use of new Defibrillator Analyzers to measure the defibrillator energy output for the ZOLL AED 3 units
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