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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.
 
DeviceLifePulse High Frequency Ventilator
Generic NameVENTILATOR, HIGH FREQUENCY
ApplicantBUNNELL, INC.
436 LAWNDALE DR.
SALT LAKE CITY, UT 84115
PMA NumberP850064
Supplement NumberS053
Date Received09/29/2023
Decision Date12/28/2023
Product Code LSZ 
Advisory Committee Anesthesiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
approval for the filter element that is included in the Camozzi Filter Assembly. The filter element, made from HDPE, has gone from a white with pink speckles color to a light blue color. All other specifications remain the same and the color change is being made to differentiate between filter elements.
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