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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 ENDOTRACHEAL TUBE ADAPTER
Classification Nameventilator, high frequency
Generic Namehigh frequency ventilator
ApplicantBUNNELL, INC.
PMA NumberP850064
Supplement NumberS012
Date Received04/11/1997
Decision Date05/16/1997
Product Code
LSZ[ Registered Establishments with LSZ ]
Advisory Committee Anesthesiology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling change to include an additional warning advising against troubleshooting while the ventilator is in operation.
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