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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 OSCILLATORY VENTILATOR
Generic NameVENTILATOR, HIGH FREQUENCY
ApplicantVyaire Medical Inc.
26125 Riverwoods Blvd
Mettawa, IL 60045
PMA NumberP890057
Supplement NumberS019
Date Received01/03/2007
Decision Date04/25/2007
Product Code LSZ 
Advisory Committee Anesthesiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE MODIFICATION OF THE BREATHING CIRCUIT TO INCLUDE TWO FILTERS, ONE IN THE INSPIRATORY LIMB AFTER THE GAS SUPPLY LINE AND RELIEVE VALVE AND ANOTHER AT THE EXPIRATORY LIMB BEFORE THE DUMP VALVE.
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