| 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. |
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| Device | Spiration® Valve System |
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| Generic Name | Valve, pulmonary |
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| Applicant | Gyrus ACMI, Inc.
6675 185th Avenue NE
Redmond, WA 98052 |
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| PMA Number | P180007 |
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| Date Received | 02/05/2018 |
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| Decision Date | 12/03/2018 |
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| Product Code |
NJK |
| Docket Number | 18M-4665 |
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| Notice Date | 12/17/2018 |
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| Advisory Committee |
Anesthesiology |
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| Clinical Trials | NCT01812447
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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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 Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S002 S003 S005 S007 S008 S009 S011 |
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