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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR
Generic NameVENTILATOR, HIGH FREQUENCY
ApplicantCovidien
6135 GUNBARREL AVE.
BOULDER, CO 80301
PMA NumberP890034
Date Received06/05/1989
Decision Date12/13/1991
Withdrawal Date 02/25/2011
Product Code LSZ 
Docket Number 91M-0508
Advisory Committee Anesthesiology
Expedited Review Granted? Yes
Combination ProductNo
Supplements:  S001 S002 S003 S004 S005 S006 
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