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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameMODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR
Classification Nameventilator, high frequency
Generic Namehigh frequency ventilator
ApplicantCOVIDIEN
PMA NumberP890034
Date Received06/05/1989
Decision Date12/13/1991
Withdrawal Date 02/25/2011
Product Code
LSZ[ Registered Establishments with LSZ ]
Docket Number 91M-0508
Advisory Committee Anesthesiology
Expedited Review Granted? Yes
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 
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