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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameIBV VALVE SYSTEM
Classification Nameone-way air-leak valve
Generic Nameone-way air-leak valve
Applicant
SPIRATION, INC.
6675 185th avenue ne
redmond, WA 98052
HDE NumberH060002
Date Received03/20/2006
Decision Date10/24/2008
Product Code
OAZ[ Registered Establishments with OAZ ]
Docket Number 08M-O579
Advisory Committee Anesthesiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the ibv® valve system. This device is indicated to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery (lvrs). An air leak present on post-operative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise. Ibv® valve system use is limited to 6 weeks per prolonged air leak.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 S004 S005 S006 S007 S008 S009 S010 
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