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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 NumberS038
Date Received10/25/2018
Decision Date11/19/2018
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  
Adding an additional supplier of the Patient Box standoffs that are used in both models of the Patient Box (312 and 314). The change proposed does not affect the performance of the Patient Box and thus the LifePulse High Frequency Ventilator is not affected. There is no change to the design or any labeling. The following manufacturing facility is affected by the change(s): Bunnell Incorporated, 436 Lawndale Drive, Salt Lake City, Utah.
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