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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameHIGH FREQUENCY OSCILLATING VENTILATOR
Classification Nameventilator, high frequency
Generic Nameventilator
ApplicantCAREFUSION
PMA NumberP890057
Supplement NumberS020
Date Received12/01/2011
Decision Date01/31/2012
Product Code
LSZ[ Registered Establishments with LSZ ]
Advisory Committee Anesthesiology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of an adhesive to the welded joints of the breathing circuit hub in the device.
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