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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 NumberS005
Date Received06/12/1995
Decision Date12/28/1995
Withdrawal Date02/25/2011
Product Code LSZ 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN PROXIMAL MONITORING ENDOTRACHEAL TUBE ADAPTER FOR USE WITH THE ADULT STAR MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR - THE PROXIMAL MONITORING ADAPTER WILL BE MARKETED UNDER THE NEW TRADE NAME AS THE "PROXIMAL MONITORING ADAPTER"
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