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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameINFANT STAR HIGH FREQUENCY VENTILATOR
Classification Nameventilator, high frequency
Generic Namehigh frequency ventilator
ApplicantNELLCOR PURITAN BENNETT, INC.
PMA NumberP880013
Date Received02/23/1988
Decision Date01/19/1990
Withdrawal Date 08/29/2007
Product Code
LSZ[ Registered Establishments with LSZ ]
Docket Number 90M-0069
Notice Date 03/16/1990
Advisory Committee Anesthesiology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S007 S008 S009 
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