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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 NameNELLCOR PURITAN BENNETT INFANT STAR HIGH FREQUENCY VENTILATOR
Classification Nameventilator, high frequency
Generic Namehigh frequency ventilator
ApplicantNELLCOR PURITAN BENNETT, INC.
PMA NumberP880013
Supplement NumberS009
Date Received04/22/2002
Decision Date12/17/2002
Product Code
LSZ[ Registered Establishments with LSZ ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional manufacturing facility located at nellcor puritan bennett, inc. , minneapolis, minnesota.
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