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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSpiration® Valve System
Generic NameValve, pulmonary
ApplicantGyrus Acmi, Inc.
6675 185th Ave. NE
Redmond, WA 98052
PMA NumberP180007
Supplement NumberS013
Date Received07/18/2024
Decision Date08/16/2024
Product Code NJK 
Advisory Committee Anesthesiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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)
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