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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceMODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR
Classification Nameventilator, high frequency
Generic Nameventilator, high frequency
Applicant
Covidien
6135 gunbarrel ave.
boulder, CO 80301
PMA NumberP890034
Supplement NumberS003
Date Received12/02/1993
Decision Date06/17/1994
Product Code
LSZ[ Registered Establishments with LSZ ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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