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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 NumberS050
Date Received05/10/2023
Decision Date05/31/2023
Product Code LSZ 
Advisory Committee Anesthesiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Replace the Thermistor Inspection Fixtures with an upgraded design. This change would increase the ease and efficiency of performing incoming inspections of the 3” thermistors (P/N 00234) and 58” thermistors (P/N 00235) which are components in the Patient Circuit used in the LifePulse HFV Systems. The new Inspection Fixtures will not affect the safety or effectiveness of the Patient Circuit or the LifePulse HFV.
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