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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.
 
DeviceMODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR
Generic NameVENTILATOR, HIGH FREQUENCY
ApplicantCovidien
6135 Gunbarrel Ave.
Boulder, CO 80301
PMA NumberP890034
Supplement NumberS006
Date Received10/15/1996
Decision Date06/24/1997
Withdrawal Date02/25/2011
Product Code LSZ 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A NEW MANUFACTURING FACILITY AT NELLCOR PURITAN BENNETT, 2200 FARADAY AVE., CARLSBAD, CA.
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