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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 and Propaq MD
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantZOLL MEDICAL CORPORATION
269 & 271 MILL ROAD
CHELMSFORD, MA 01824-4105
PMA NumberP160022
Supplement NumberS018
Date Received05/29/2020
Decision Date06/11/2020
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  
Add an additional manufacturing site for a supplier of printed circuit boards for the X Series and Propaq MD.
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