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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 NumberS039
Date Received02/27/2019
Decision Date06/14/2019
Product Code LSZ 
Advisory Committee Anesthesiology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the manufacturer of the injection molded parts including the Patient Circuit Cartridge halves, Cartridge Back and Cartridge Front, and the LifePort Adapters Patient End and Machine End, all sizes.
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