Model 3100A/B High Frequency Oscillatory Ventilator

FDA Premarket Approval P890057 S025

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.

Pre-market Approval Supplement Details

DeviceModel 3100A/B High Frequency Oscillatory Ventilator
Generic NameVentilator, High Frequency
ApplicantVyaire Medical Inc.26125 Riverwoods Blvdmettawa, IL 60045 PMA NumberP890057 Supplement NumberS025 Date Received04/25/2022 Decision Date07/22/2022 Product Code LSZ  Advisory Committee Anesthesiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-04-25
Decision Date2022-07-22
PMAP890057
SupplementS025
Product CodeLSZ 
Advisory CommitteeAnesthesiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressVyaire Medical Inc.
26125 Riverwoods Blvd
mettawa, IL 60045 PMA NumberP890057 Supplement NumberS025 Date Received04/25/2022 Decision Date07/22/2022 Product Code LSZ  Advisory Committee Anesthesiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval For Modifications To The Material Of Construction Of Your 3100A/B Bellows Water Trap Assembly

Supplemental Filings

Supplement NumberDateSupplement Type
P890057Original Filing
S025 2022-04-25 Real-time Process
S024
S023
S022 2014-04-29 30-day Notice
S021 2013-10-28 30-day Notice
S020 2011-12-01 135 Review Track For 30-day Notice
S019 2007-01-03 Real-time Process
S018 2004-12-20 Real-time Process
S017 2004-07-14 Normal 180 Day Track No User Fee
S016
S015 2001-08-09 Normal 180 Day Track
S014 2001-02-22 Panel Track
S013 1999-11-19 Normal 180 Day Track
S012
S011
S010 1997-07-03 Normal 180 Day Track
S009 1997-05-16 Normal 180 Day Track
S008 1997-01-03 Normal 180 Day Track
S007 1996-02-26 Normal 180 Day Track
S006
S005 1993-03-15 Normal 180 Day Track
S004 1993-02-09 Normal 180 Day Track
S003 1992-06-29 Panel Track
S002 1992-02-03 Normal 180 Day Track
S001 1991-04-04 Normal 180 Day Track

NIH GUDID Devices

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