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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 (HFV)
Generic NameVENTILATOR, HIGH FREQUENCY
ApplicantBunnell, Inc.
436 Lawndale Dr.
Salt Lake City, UT 84115
PMA NumberP850064
Supplement NumberS055
Date Received10/02/2024
Decision Date07/25/2025
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  
for a change to materials in the Patient Circuit based on their biocompatibility profile. The changes include: a change to circuit tubing material (no change to tubing type or dimensions), change in the anodization process of the heater cup, and replacing the adhesives used with medical grade adhesives.
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