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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 OSCILLATING VENTILATOR
Generic NameVENTILATOR, HIGH FREQUENCY
ApplicantVyaire Medical Inc.
26125 Riverwoods Blvd
Mettawa, IL 60045
PMA NumberP890057
Supplement NumberS020
Date Received12/01/2011
Decision Date01/31/2012
Product Code LSZ 
Advisory Committee Anesthesiology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF AN ADHESIVE TO THE WELDED JOINTS OF THE BREATHING CIRCUIT HUB IN THE DEVICE.
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