PMA P180007S013

Device: Spiration® Valve System
Applicant: Gyrus Acmi, Inc.
PMA number: P180007
Supplement: S013
Product code: NJK
Decision date: 2024-08-16
Classification: Anesthesiology
Generic name: Valve, pulmonary
Approval order 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)

Current openFDA PMA Record#

Device: Spiration® Valve System
Applicant: Gyrus Acmi, Inc.
PMA number: P180007
Supplement: S013
Product code: NJK
Generic name: Valve, pulmonary
Decision date: 2024-08-16
Decision code: OK30
Date received: 2024-07-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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)