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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.
 
DeviceHIGH FREQUENCY OSCILLATORY VENTILATOR
Generic NameVENTILATOR, HIGH FREQUENCY
ApplicantVyaire Medical Inc.
26125 Riverwoods Blvd
Mettawa, IL 60045
PMA NumberP890057
Supplement NumberS015
Date Received08/09/2001
Decision Date01/08/2002
Product Code LSZ 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF A MODIFICATION TO THE DESIGN OF THE DRIVER DIAPHRAGM IN THE DEVICE.
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