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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.
 
DeviceHIGH FREQUENCY VENTILATOR
Generic NameVENTILATOR, HIGH FREQUENCY
ApplicantNELLCOR PURITAN BENNETT, INC.
2200 FARADAY AVE.
CARLSBAD, CA 92008-7208
PMA NumberP880013
Supplement NumberS007
Date Received10/11/1996
Decision Date06/24/1997
Withdrawal Date 08/29/2007
Product Code LSZ 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE AT NELLCOR PURITAN BENNETT, 2200 FARADAY AVE., CARLSBAD, CA.
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