Spiration® Valve System
FDA premarket approval P180007 · decided 2018-12-03
Approval details
- PMA number
- P180007
- Trade name
- Spiration® Valve System
- Generic name
- Valve, pulmonary
- Applicant
- Gyrus Acmi, Inc.
- Date received
- 2018-02-05
- Decision date
- 2018-12-03
- Days to decision
- 301 days
- Decision code
- APPR
- Product code
- NJK
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Redmond, WA
- 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.
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