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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device one-way air-leak valve
Definition To restrict air flow to the target section of the lung. 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.
Product CodeOAZ
Device Class Humanitarian Device Exemption

Device Problems
No Known Device Problem 2
Not Applicable 1
Total Device Problems 3

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