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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.
 
DeviceModel 3100A/B High Frequency Oscillatory Ventilator
Generic NameVENTILATOR, HIGH FREQUENCY
ApplicantZOLL Medical Corporation
269 Mill Rd.
Chelsmford, MA 01824
PMA NumberP890057
Supplement NumberS025
Date Received04/25/2022
Decision Date07/22/2022
Product Code LSZ 
Advisory Committee Anesthesiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modifications to the material of construction of your 3100A/B bellows water trap assembly.
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