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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.
 
DeviceX Series Advanced Devices
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantZOLL Medical Corporation
269 & 271 Mill Rd.
Chelsmford, MA 01824
PMA NumberP160022
Supplement NumberS028
Date Received04/23/2021
Decision Date05/19/2021
Product Code MKJ 
Advisory Committee Cardiovascular
Clinical TrialsNCT04014842
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) protocol.
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