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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.
 
DeviceHIGH FREQUENCY OSCILLATING VENTILATOR
Classification Nameventilator, high frequency
Generic Nameventilator, high frequency
Applicant
CareFusion
75 north fairway drive
vernon hills, IL 60061
PMA NumberP890057
Supplement NumberS020
Date Received12/01/2011
Decision Date01/31/2012
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 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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