Spiration® Valve System
FDA premarket approval P180007/S013 · decided 2024-08-16
Approval details
- PMA number
- P180007
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Spiration® Valve System
- Generic name
- Valve, pulmonary
- Applicant
- Gyrus Acmi, Inc.
- Date received
- 2024-07-18
- Decision date
- 2024-08-16
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NJK
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- Addition of a supplier for microbial monitoring nutrient media plates, nutrient media incubation and plate counting Addition of a supplier for an active air sampler Minor updates to the Olympus Redmond Environmental Monitoring, Controlled Environment Work Instruction (WI)
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