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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 3100B HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV)
Classification Nameventilator, high frequency
Generic Nameventilator, high frequency
Applicant
Vyaire Medical Inc.
26125 riverwoods blvd
mettawa, IL 60045
PMA NumberP890057
Supplement NumberS014
Date Received02/22/2001
Decision Date09/24/2001
Product Code
LSZ[ Registered Establishments with LSZ ]
Docket Number 01M-0520
Notice Date 11/19/2001
Advisory Committee Anesthesiology
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE MODEL 3100B HFOV. THE DEVICE IS INDICATED FOR USE IN THE VENTILATORY SUPPORT AND TREATMENT OF SELECTED PATIENTS 35 KILOGRAMS AND GREATER WITH ACUTE RESPIRATORY FAILURE.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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