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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNELLCOR PURITAN BENNETT INFANT STAR HIGH FREQUENCY VENTILATOR
Classification Nameventilator, high frequency
Generic Nameventilator, high frequency
Applicant
NELLCOR PURITAN BENNETT, INC.
2200 faraday ave.
carlsbad, CA 92008-7208
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 express gmp supplement
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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