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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DeviceSpiration® Valve System
Generic NameValve, pulmonary
ApplicantGyrus ACMI, Inc.
6675 185th Avenue NE
Redmond, WA 98052
PMA NumberP180007
Date Received02/05/2018
Decision Date12/03/2018
Product Code NJK 
Docket Number 18M-4665
Notice Date 12/17/2018
Advisory Committee Anesthesiology
Clinical TrialsNCT01812447
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval of the Spiration® Valve System. The Spiration® Valves are one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have low collateral ventilation.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S002 S003 S005 S007 S008 S009 S011