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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.
 
DeviceModel 203 Life Pulse High Frequency Ventilator
Generic NameVENTILATOR, HIGH FREQUENCY
ApplicantBUNNELL, INC.
436 LAWNDALE DR.
SALT LAKE CITY, UT 84115
PMA NumberP850064
Supplement NumberS037
Date Received09/20/2018
Decision Date10/19/2018
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  
The LifePulse High Frequency Ventilator is indicated for use in ventilating critically ill infants with pulmonary interstitial emphysema (PIE). Infants studied ranged in birth weight from 750 to 3,529 grams and in gestational age from 24 to 41 weeks. The LifePulse High Frequency Ventilator is also indicated for use in ventilating critically illinfants with respiratory distress syndrome (RDS) complicated by pulmonary air leaks who are, in the opinion of their physicians, failing on conventional ventilation. The infantsstudied ranged in birth weight from 600 to 3,660 grams and in gestational age from 24 to 38 weeks.
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