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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 NameLIFE PULSE HIGH FREQUENCY VENTILATOR, 203/203A
Classification Nameventilator, high frequency
Generic Namehigh frequency ventilator
ApplicantBUNNELL, INC.
PMA NumberP850064
Supplement NumberS021
Date Received09/07/2012
Decision Date05/16/2013
Product Code
LSZ[ Registered Establishments with LSZ ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the insulation material on the raw heater wire in the patient circuit.
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