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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 3100A HIGH FREQUENCY OCILLATORY VENTILATOR
Classification Nameventilator, high frequency
Generic Nameventilator, high frequency
Applicant
Vyaire Medical Inc.
26125 riverwoods blvd
mettawa, IL 60045
PMA NumberP890057
Supplement NumberS009
Date Received05/16/1997
Decision Date07/08/1997
Product Code
LSZ[ Registered Establishments with LSZ ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A CHANGE IN THE MANUFACTURING OF THE PATIENT CIRCUIT TO ULTRASONIC WELDING.
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